Regulatory affairs associate work from home jobs - 96 jobs
Remote Regulatory Affairs Consultant (Strategy)
Pharmatech Associates 3.6
Remote job
A leading consulting firm in regulatory affairs is seeking a Regulatory Affairs Consultant to work remotely, supporting ongoing projects with 10-20 hours per week. You will lead the development and execution of regulatory strategies, engage with the FDA, and provide guidance throughout product development. The ideal candidate will have an advanced degree in science or biomedical engineering and a minimum of 10 years of experience in regulatory applications. Join a diverse and inclusive team dedicated to impactful work.
#J-18808-Ljbffr
$72k-102k yearly est. 5d ago
Looking for a job?
Let Zippia find it for you.
Chief Legal & Commercial Officer - Remote-Eligible Infra
Axiompmp
Remote job
A leading consulting firm is seeking a General Counsel & Chief Commercial Officer to manage all legal aspects and commercial strategy in Seattle, Washington. The role involves overseeing legal compliance, negotiating contracts, and managing risks on multi-billion-dollar infrastructure projects. Candidates must possess a Juris Doctor degree, be licensed to practice in the U.S., and have over 10 years of experience with federal projects. Telecommuting is allowed, with some domestic travel required.
#J-18808-Ljbffr
$65k-123k yearly est. 4d ago
US Regulatory Affairs Specialist
Henry Schein 4.8
Remote job
This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company's ongoing compliance.
KEY RESPONSIBILITIES:
Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company's ongoing compliance with Federal, State and local requirements.
Initiate and maintain medical device product registrations globally, focusing on international markets.
Support the development of Regulatory strategies and processes.
Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets.
Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations.
Assist in SOP development and review.
Provide regulatory input to product lifecycle planning.
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Determine and communicate submission and approval requirements
Participate in risk benefit analysis for regulatory compliance
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare, review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies
Monitor applications under regulatory review
Provide support during inspections and formulating the appropriate response and corrective actions
Assist compliance with product post marketing approval requirements
Review regulatory aspects of contracts
Assist with label and Instructions for Use (IFU) development and review for compliance before release
Ability to manage multiple establishment and product registration activities
Submit and review change controls to determine the level of change and consequent submission requirements
Provide regulatory input for product recalls and recall communications
Other duties as assigned.
SPECIFIC KNOWLEDGE & SKILLS:
2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions.
Experience with FDA pre-market submissions preferred.
Experience with ISO 13485 and EU MDR preferred
GENERAL SKILLS & COMPETENCIES:
Good understanding of industry practices
Proficient with tools, systems, and procedures
Basic planning/organizational skills and techniques
Good decision making, analysis and problem solving skills with ability to multi-task
Good verbal and written communication skills
Good presentation and public speaking skills
Good interpersonal skills
Basic conflict resolution skills
Developing professional credibility
MINIMUM WORK EXPERIENCE:
Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience.
PREFERRED EDUCATION:
Typically a Bachelor's Degree or global equivalent in related discipline.
TRAVEL / PHYSICAL DEMANDS:
Travel typically less than 10%. Office environment. No special physical demands required.
The posted range for this position is $61,812-$84,992, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.
This position is eligible for a bonus not reflected in the posted range.
Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
For more information about career opportunities at Henry Schein, please visit our website at: ***************************
Fraud Alert
Henry Schein has recently been made aware of multiple scams where unauthorized individuals are using Henry Schein's name and logo to solicit potential job seekers for employment.
Please be advised that Henry Schein's official U.S. website is
*******************
. Any other format is not genuine. Any jobs posted by Henry Schein or its recruiters on the internet may be accessed through Henry Schein's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with Henry Schein are advised to verify the job posting through this portal.
No money transfers, payments of any kind, or credit card numbers, will EVER be requested from applicants by Henry Schein or any recruiters on its behalf, at any point in the recruitment process.
$61.8k-85k yearly Auto-Apply 32d ago
Regulatory and Government Affairs - Associate Director (NY / Remote)
KBRA 3.7
Remote job
Regulatory and Government Affairs - Associate Director (NY / Remote)
Entity: KBRA Holdings LLC
Employment Type: Full-Time
Location: New York, New York or Remote (Remote only in CA, CO, DC, FL, IL, MD, NJ, MA, NY, PA, SC, TX, VA)
Summary:
KBRA's Regulatory and Government Affairs team is seeking a highly motivated Associate Director to support the firm's engagement with regulators, policymakers, and industry stakeholders. This position offers a unique opportunity to participate in conversations at the intersection of financial regulation, capital markets, and public policy.
The Associate Director will assist in monitoring regulatory and legislative developments, conducting policy research, and preparing materials for internal and external audiences. This position is ideal for candidates who have studied Public Policy, Political Science, Economics, Law, International Relations, Finance, or a related field and who have demonstrated experience in applying their research and analytical skills to real-world regulatory and policy issues.
About the Job:
Regulatory and Legislative Monitoring: Track and summarize relevant legislative, regulatory, and policy developments affecting credit rating agencies and the broader financial services sector.
Policy Research and Analysis: Conduct in-depth research and draft analyses on key policy areas such as capital markets regulation, financial stability, ESG disclosure frameworks, and credit ratings oversight.
Briefing Materials: Prepare policy briefs, internal memoranda, issue summaries, and talking points for senior leadership ahead of meetings with regulators, trade associations, and policymakers.
Stakeholder Engagement: Support and participate in preparation for policy roundtables, industry consultations, and conferences involving government or regulatory representatives.
Cross-Functional Collaboration: Work closely with teams across KBRA including Legal, Compliance, and Communications to maintain consistent and informed policy messaging.
Special Projects: Contribute to strategic initiatives related to regulatory trends, public policy priorities, and global coordination efforts.
You will be successful in this role if you possess:
Bachelor's or Master's degree in Public Policy, Political Science, Economics, Law, International Relations, Finance, or a related field.
Minimum four years of experience in financial regulation, public policy, or government affairs.
Excellent research, writing, and analytical skills, with the ability to distill complex policy issues clearly and accurately.
Strong organizational skills and attention to detail, and ability to manage multiple projects simultaneously.
Ability to work both independently and collaboratively in a fast-paced professional environment.
Proficiency with Microsoft Office Suite; familiarity with legislative tracking tools, regulatory databases, or financial market research platforms is a plus.
Familiarity with Generative AI tools such as ChatGPT for research, data insights, and general productivity is a plus.
What You will Gain:
Direct exposure to the regulatory and policy landscape shaping the global credit rating industry.
Opportunities to work with KBRA's experienced regulatory and government affairs professionals on meaningful policy issues.
Insight into how a leading credit rating agency engages with regulators, legislators, and industry bodies.
A deep understanding of how regulatory policy impacts capital markets and credit analysis.
Skill development in policy analysis, stakeholder engagement, and cross-functional collaboration.
A collaborative and mission-driven culture that values independence, integrity, and analytical excellence.
Salary Range:
The anticipated annual base salary range for this full-time position is $120,000 - $150,000. Offer amounts are determined by factors such as experience, skills, geography, and other job-related factors.
Benefits:
A flexible hybrid work schedule - Tuesdays, Wednesdays, Thursdays in the office
Competitive benefits and paid time off
Paid family and disability leave
401(k) plan, including employer match (100% vested)
Educational and professional development financial assistance
Employee referral bonus program
About Us:
KBRA is a full-service credit rating agency registered in the U.S., the EU and the UK, and is designated to provide structured finance ratings in Canada. KBRA's ratings can be used by investors for regulatory capital purposes in multiple jurisdictions.
More Info:
KBRA encourages applications from all qualified individuals without regard to race, color, religion, gender, sexual orientation, gender identity or expression, age, national origin, marital status, citizenship, disability, and veteran status or any other basis prohibited by federal, state or local law.
#LI-KS1
#Remote
$120k-150k yearly Auto-Apply 21d ago
Global Regulatory Affairs - CMC Talent Community
Telix Pharmaceuticals
Remote job
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
Stay Connected with Telix for Future or Upcoming Regulatory Affairs - CMC Opportunities
Telix is always looking to connect with great talent in the market! While we may not have the position you're looking for open today, we'd love for you to share your information with us for future openings. This post is not for a specific role or territory, but we can reach out when an opening comes available.
See Yourself at Telix
The Global Regulatory CMC team is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. This team will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs.
Key Accountabilities
Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness.
Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.
Education and Experience
Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred.
Experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks.
Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies.
Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3.
Interested in joining our mission?
Submit your information and let's stay connected!
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
VIEW OUR PRIVACY POLICY HERE
$58k-86k yearly est. Auto-Apply 11d ago
Head of Regulatory Affairs - US & Canada, PDx
Gehc
Remote job
SummaryThis role reports to the Global Head of Regulatory Affairs GE HealthCare's Pharmaceutical Diagnostics (PDx). This role provides strategic regulatory leadership for GE HealthCare's Pharmaceutical Diagnostics (PDx) business across the US and Canada. This role drives regulatory strategy for product development, submissions, approvals, and post-market compliance, ensuring alignment with business objectives and regulatory requirements. Acts as the primary liaison with FDA, Health Canada, and other authorities, influencing outcomes and accelerating time-to-market.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job Description
Key Responsibilities:
Regulatory Strategy & Execution
Develop and implement regional regulatory strategies to enable timely product approvals and lifecycle management.
Interpret regulatory trends and business challenges to recommend best practices that enhance compliance and accelerate product development.
Agency Engagement
Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries.
Represent GE HealthCare PDx in regulatory meetings and industry forums.
Cross-Functional Leadership
Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies.
Support the RA team providing regulatory guidance on labeling, advertising, and promotional materials.
Team Leadership
Lead and mentor a team of regulatory professionals; set priorities, allocate resources, and ensure timely, high-quality deliverables.
Foster a culture of compliance, agility, and continuous improvement.
Governance & Compliance
Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers.
Drive initiatives to improve regulatory efficiency and proactively manage compliance risks.
Business Support
Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements.
Support budget planning for the Regulatory Affairs function.
Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in US and Canadian markets.
Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components.
Experience leading meetings with FDA and Health Canada.
Background in sterile injectables; radiopharmaceutical experience is a strong asset.
Desired Characteristics:
Strategic thinker with strong analytical and problem-solving skills.
Excellent oral and written communication; ability to influence and negotiate effectively.
Proven leadership and team development capabilities.
Strong project management and organizational skills; ability to manage complex priorities.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $180,000.00-$270,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Application Deadline: February 09, 2026
$58k-86k yearly est. Auto-Apply 21d ago
Global Head of Regulatory Affairs
VM Agritech Inc.
Remote job
Job DescriptionBenefits:
Health insurance
Paid time off
Stock options plan
Vision insurance
Reports To: CEO Employment Type: Full-Time About VM Agritech (VMA)
At VM Agritech, we develop science-driven products that protect the health of plants, people, and soil. Our innovations deliver powerful results without compromising what matters. We provide solutions that are effective against pathogens and supportive of healthier plants, people, and ecosystems.
Position Summary
The Global Head of Regulatory Affairs is a key role within the growing global business at VMA. VM Agritechs first core products, Curezin and MiCure have received regulatory clearance in the USA, and we now need to obtain regulatory clearance for these and other new products around the world.
Were looking for an experienced Executive with hands-on experience of the global regulatory environment for agricultural products. The Executive will be responsible for identifying and working with Regulatory Consultants around the world to obtain timely approval for VMAs products and all regulatory filings worldwide.
Key Responsibilities
Reporting to CEO
The regulatory obligations of an agrochemical company are considerable; VMAs Regulatory Affairs (RA) will be responsible for and the head of RA will be VMAs penultimate authority on:
Adherence to FIFRA and 50 US state-level FIFRA equivalents
documentation
submission
maintenance / vigilance / audits
Compliance with 50 US state-level administrators for fertilizer and adjuvant registrations, and tonnage reporting {documentation}
submission
maintenance / vigilance / audits
Responsible for all aspects of the regulatory process and interaction with regulators globally
Key Executive in the decision process for timing and type of market access by country/region
Qualifications
Demonstrated understanding of the global regulatory environment at a granular level
High level academic background, ideally in an agricultural biology or chemistry specialization
Interacted with regulators and senior Governmental officials
Run consultants and a team of people to execute regulatory strategy.
Based either in the USA or Europe. Prepared and able to travel extensively given the nature of the role.
Benefits
Highly Competitive salary
401(k) with company match
Fully company-paid health, dental, and vision insurance
Flexible work arrangements and paid time off (PTO)
Stock options
Fully remote position
This is a remote position.
$58k-85k yearly est. 17d ago
Senior Regulatory Affairs Specialist (Remote - United States)
Healthcare Services 4.1
Remote job
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
Senior Regulatory Affairs Specialist
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
As a Senior Regulatory Affairs Specialist, you will have responsibility for managing the regulatory compliance for a portfolio of medical devices within the Infection Prevention and Surgical Solutions business. The portfolio of devices includes Class Is, II and III in the EU as well as 510(k) requirements in the US. This role will support on-going product compliance throughout the device's lifecycle allowing you the opportunity to build strong relationships with stakeholders and management.
In this role, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims.
Managing complex decision-making among cross‑functional stakeholders in an area of regulatory that is complex and evolving.
Participating in global business and functional strategic meetings and forums representing regulatory affairs.
Performing regulatory assessments and determining registration plans with the business for strategic implementation.
Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements.
Submitting registration documents and following through on all in‑process evaluations until regulatory authorization is obtained.
Acting as the focal point for commercial support pertaining to all regulatory activities.
Managing regulatory systems and tools to drive operational excellence for effective data tracking and to ensure regulatory data integrity.
Keeping abreast of new regulations and providing necessary regulatory information, updates, and documentation to the organization.
Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits.
Supporting any other duties within the role or tasks assigned from time to time.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Bachelor's Degree or higher (completed and verified) from an accredited institution AND five (5) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment
OR
High School Diploma/GED (completed and verified prior to start) from an accredited institution and nine (9) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment
In addition to the above requirements, the following are also required:
Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions
Additional qualifications that could help you succeed even further in this role include:
Advanced degree in Scientific, Engineering or Regulatory/Quality.
Experience supporting 13485 and MDSAP audits.
New Product Introductions (NPI) experience.
Five (5) years of experience with regulatory submissions which may include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions.
Work location:
Remote in the United States
Travel: May include up to 10% domestic/international
Relocation Assistance: Is not authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Applicable to US Applicants Only:The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement
Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.
Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the
terms.
$124k-170.5k yearly Auto-Apply 8d ago
Senior Regulatory Affairs Specialist (Remote - United States)
Solventum
Remote job
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
Senior Regulatory Affairs Specialist
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
As a Senior Regulatory Affairs Specialist, you will have responsibility for managing the regulatory compliance for a portfolio of medical devices within the Infection Prevention and Surgical Solutions business. The portfolio of devices includes Class Is, II and III in the EU as well as 510(k) requirements in the US. This role will support on-going product compliance throughout the device's lifecycle allowing you the opportunity to build strong relationships with stakeholders and management.
In this role, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims.
Managing complex decision-making among cross‑functional stakeholders in an area of regulatory that is complex and evolving.
Participating in global business and functional strategic meetings and forums representing regulatory affairs.
Performing regulatory assessments and determining registration plans with the business for strategic implementation.
Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements.
Submitting registration documents and following through on all in‑process evaluations until regulatory authorization is obtained.
Acting as the focal point for commercial support pertaining to all regulatory activities.
Managing regulatory systems and tools to drive operational excellence for effective data tracking and to ensure regulatory data integrity.
Keeping abreast of new regulations and providing necessary regulatory information, updates, and documentation to the organization.
Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits.
Supporting any other duties within the role or tasks assigned from time to time.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Bachelor's Degree or higher (completed and verified) from an accredited institution AND five (5) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment
OR
High School Diploma/GED (completed and verified prior to start) from an accredited institution and nine (9) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment
In addition to the above requirements, the following are also required:
Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions
Additional qualifications that could help you succeed even further in this role include:
Advanced degree in Scientific, Engineering or Regulatory/Quality.
Experience supporting 13485 and MDSAP audits.
New Product Introductions (NPI) experience.
Five (5) years of experience with regulatory submissions which may include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions.
Work location:
Remote in the United States
Travel: May include up to 10% domestic/international
Relocation Assistance: Is not authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Applicable to US Applicants Only:The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement
Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.
Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the
terms.
$124k-170.5k yearly Auto-Apply 8d ago
Senior Regulatory Affairs Specialist (Remote)
Environmental Science 3.7
Remote job
Shift:
Monday through Friday, 8:00 AM - 5:00 PM (with some flexibility)
Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.
Lead and execute global regulatory strategies to ensure our client's investigational, new, and marketed products are developed and maintained in compliance with global regulatory requirements. Serve as a strategic advisor to clients, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.
Compensation: $150,000.00 - 175,000.00 per year
Key Responsibilities:
Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
Strategy Implementation: Prepare and Lead Regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement.
Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations.
Other duties as assigned.
Ideal Candidate:
B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field with a minimum of 10+ years of experience in CMC /regulatory affairs
Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.
Excellent attention to detail, technical writing, organizational, and communication skills.
Ability to manage multiple deliverables and timelines in a fast-paced environment.
Proficiency with regulatory document management systems.
Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.
Benefits
When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.
Equal Opportunity Employer
Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
$150k-175k yearly Auto-Apply 60d+ ago
Senior Regulatory Affairs Specialist
Cordance
Remote job
Cordance is dedicated to accelerating the growth of vertically focused business-to-business (B2B) software-as-a-service (SaaS) companies through acquisition and long-term tactical and financial guidance. We're experienced operators and subject-matter experts with a passion for software and building businesses. We partner with founders to help them scale their businesses and realize their companies' full potential.
We look for businesses with strong leadership and high potential for profitable growth, and work together to increase year-over-year revenue, company efficiency, and impact. Cordance envisions that all companies we work with achieve their full potential. We embrace what makes each company great and build on those foundations. We believe in elevating a company as it scales, delivering dignity to the organization and its employees, and sharing a passion for building a legacy.
Ithos Global is an information management company and regulatory compliance leader in helping cosmetic, personal care, and OTC companies meet their global product compliance standards Based on specific client needs related to regulatory compliance, Ithos uses state-of-the-art technology to deliver its services and tools.
As a rapidly growing business, Ithos is in search of a Senior Regulatory Affairs Specialist to meet the demands of this marketplace. We are looking for individuals who possess a strong attention to detail and recognition of issues, someone who is highly motivated, and has a positive attitude to add to our Regulatory Team.
Location
This position is fully remote with an occasional need for business travel.
Responsibilities
As an Ithos Global Regulatory Affairs Senior Specialist, you will be responsible to support and advise on a vast array of end-to-end Regulatory Affairs topics for the product categories of Cosmetics, Personal Care, Consumer Products, and OTCs. Some role activities will also fall under the areas of the knowledge and use of Ithos Information Network (IIN) System:
Various Regulatory Tasks and the Management of them including: Documentation and review, global formula compliance screenings, ingredient policies, Ingredient Listings, global registrations and notifications, and Safety Data Sheet authoring
Label, claims, and testing protocol reviews
Ownership of client relationships and projects
Training of employees
Research of regulations and related information
Trade council engagement
Projects may also be assigned with an expectation of project management and leadership which will relate to Team and Company objectives
Additional Expectations
This role has added expectations for leadership in the areas of project deliverables and client relationships as well as process improvements and a call to action on issues. An established point of view on topics of regulatory risk, software enhancements, project leadership, and the global regulatory landscape and surveillance is also necessary. This role acts independently to provide client advisement and deliverables with the support of other team associates. Technical knowledge and research ability skills should be developed and utilized as a resource for the company and Team.
Qualifications
College graduate with degree in related field of biological sciences, chemistry, physics, cosmetic science, political science
5-10 years of experience in Cosmetic and Personal Care Regulatory Affairs
Experience with the use of compliance software, integration, and regulation content management
Please note that we do not accept unsolicited resumes, work on a Corp-to-Corp basis, or engage with non-vetted external agencies.
Why Join Us?
At Cordance, we believe in taking care of our team members. When you join us, you'll enjoy a comprehensive benefits package designed to support your health, financial well-being, and work-life balance:
Health and Wellness:
Comprehensive Health Coverage: Coverage begins on your first day of employment.
Retirement Savings:
401K Plan (US): We match 1:1 for the first 3% of contributions and 0.5:1 for the next 2%. Contribute 5% of your salary and get a 4% match. Choose from pre-tax and Roth options. You're eligible the first of the month after 90 days and immediately vested.
RRSP (CAN): We match 1:1 for the first 3% of contributions and 0.5:1 for the next 2%. Contribute 5% of your salary and get a 4% match. Choose from pre-tax and Roth options. You're eligible the first of the month after 90 days and immediately vested.
Paid Time Off:
Flexible PTO: Enjoy uncapped paid time off to balance your work and personal life.
Parental Leave:
12 weeks paid leave for all employees.
Remote Work Support:
Monthly Stipend: Receive $75 USD / $140 CAD per month for phone and internet if you work remotely.
Holidays:
Generous Holiday Schedule: Benefit from an extensive list of holidays to recharge and spend time with loved ones.
Join us and be part of a company that values your contributions and well-being from day one!
EEOC & ADA Statement
: Cordance and its companies provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, creed, sex, nationality, ancestry, national origin, disability status, genetics, protected veteran status, affectional or sexual orientation, gender identity or expression, marital status, or any other characteristic protected by federal, state, or local laws. Cordance and its companies comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Final candidate must be able to pass a background check. To view applicant notices required under federal and state law, please visit: **************************************
$58k-84k yearly est. Auto-Apply 21d ago
Head of Americas Licensing and Regulatory Affairs
Openfx
Remote job
About Us
OpenFX is on a mission to move money as freely as data, unrestricted by time zones, banking hours, or legacy systems. We are building the infrastructure that will power the next generation of cross-border payment systems for institutions. The team's execution has been exceptional, and we're scaling at a remarkable pace. Our stellar early team comes with experience in companies like J.P. Morgan, Goldman Sachs, FalconX, Paypal, Affirm, Polygon, Kraken, Nium & others. We're backed by Accel, Lightspeed, NfX and other top-tier investors.
Role Overview
We are seeking a Head of Americas Licensing and Regulatory Affairs to join our dynamic team. The role will be responsible for driving our acquisition of U.S. state money transmitter licenses and subsequent management of those licenses and our relationships with U.S. state regulators, as well as the acquisition of other licenses to support the rapid growth of our business in the U.S., Canada and Latin America. This role is crucial for enabling our global expansion while maintaining regulatory compliance and strong relationships with regulatory authorities.
Key Responsibilities:
Licensing Acquisition & Maintenance
Complete execution of pending US state money transmitter license (MTL) applications: Complete preparation, coordination, and submission of MTL applications across all required US states, managing multiple applications simultaneously through approval
Drive scoping and execution of additional license applications in the Americas: Prepare and submit Money Services Business (MSB) registration in Canada, obtain required U.S. crypto/virtual currency licenses, and secure any required licenses across key Latin American markets.
Coordinate with external counsel and consultants: Manage relationships with licensing consultants and outside counsel to ensure high-quality, cost-effective support aligned with business needs
Manage license maintenance activities: Oversee all post-licensing obligations including renewals, amendments, quarterly/annual reporting, surety bond management, net worth requirements, and permissible investment compliance
Regulatory Relations and Compliance Operations
Serve as primary regulatory contact: Act as OpenFX's main point of contact with state banking departments, FinCEN, and other US regulators, as well as FINTRAC (Canada) and Latin American financial authorities
Build and maintain regulator relationships: Establish positive, proactive relationships with key regulatory bodies, positioning OpenFX as a compliant and transparent operator
Manage regulatory inquiries and examinations: Lead preparations for and responses to regulatory examinations, audits, inquiries, and requests for information from state and federal regulators
Prepare regulatory submissions: Draft, review, and submit all regulatory filings, notifications, reports, and correspondence with accuracy and within required timelines
Prepare and manage regulatory reports and filings: Coordinate with Finance and other internal stakeholders to submit quarterly, semi-annual, and annual financial and operational reports required under various licenses
Cross-Functional Collaboration
Support market expansion: Work with internal teams to identify regulatory requirements for new markets and develop paths to licensure
Maintain policies and procedures: Review and update regulatory policies, procedures, and compliance manuals to reflect current requirements
Build and develop the team: As the business scales, recruit and manage licensing and regulatory professionals
What we are looking for
Required Qualifications
7+ years of experience in regulatory licensing, regulatory affairs, or regulatory compliance within financial services, fintech, or payments companies
Proven track record of successfully obtaining and maintaining financial services licenses, particularly US state money transmitter licenses
Strong knowledge of US state money transmission regulatory frameworks, including application processes, surety bond requirements, net worth rules, and examination procedures
Regulatory filing expertise: Demonstrated experience preparing and submitting regulatory reports, notifications, and responses to regulatory inquiries
Regulator relationship experience: Track record of successfully interfacing with state banking departments, FinCEN, and other financial regulators
Exceptional project management skills: Ability to manage multiple complex, time-sensitive licensing applications and compliance obligations simultaneously
Outstanding written communication skills: Experience drafting regulatory submissions, applications, policies, and correspondence to regulators
Meticulous attention to detail: Strong analytical skills with ability to navigate complex regulatory requirements and ensure accuracy in all submissions
Collaborative approach: Commitment to teamwork and ability to work effectively with cross-functional teams and external advisors
Bachelor's degree required; JD preferred
What helps you stand out:
Experience in cross-border payments, FX, or crypto industries
Experience with crypto/digital asset licensing (e.g., NY BitLicense, state virtual currency licenses)
Experience with international licensing (Canada MSB registration, Latin American licenses)
Prior work at a high-growth fintech or payments startup managing rapid licensing expansion
Existing relationships with state regulators, CSBS, or Money Transmitter Regulators Association (MTRA)
Familiarity with RegTech tools and automation for regulatory compliance and reportin
What We Offer
Competitive salary and benefits package
Impact: Own the licensing function at a critical growth stage and directly enable business expansion
Growth: Opportunity to build a function and help scale a successful high-growth company
Learning: Opportunity to work in a fast-paced startup at the forefront of fintech innovation.
Culture: Collaborative team environment with emphasis on personal and professional growth
Mission: Help build the future of global financial infrastructure
We are committed to building a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
$58k-84k yearly est. Auto-Apply 28d ago
Exam Coordinator III- Regulatory Mortgage
Newrez
Remote job
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering our employees by encouraging and recognizing superior performance and innovative solutions, by promoting teamwork and divisional cooperation.
Primary Function
This position plays a critical role in the success of Newrez by managing the end-to-end process associated with examinations. The Exam Coordinator III facilitates the exam management process, which includes interaction with all levels of management and departments across the organization as well as regulators.
Principal Duties
List of required duties below. Distinguish on-site duties with a *.
* Responsible for the project management functions related to managing all regulatory and third-party client exams.
* Primary focus is high-profile exams such as Freddie, Fannie, Ginnie Mae, FHA, VA, etc.
* Must also be able to facilitate State/Client/Joint Venture exams.
* Prepare exam decks per examiners' agenda requirements.
* Delegate tasks to other team members as applicable to meet deadlines.
* Provide assistance with new hire training of dept. functions.
* Primary contact with regulatory agencies and clients for all external exams. Including timely follow-ups on examiners' requests.
* Work directly with all levels of management throughout the organization to gather evidence related to exam requests.
* Coordinate onsite and remote examiner requests for information.
* Responsible for escalating any regulator concerns, emerging themes, or issues and driving action.
* Partner with Training for exam preparation business units for interacting with regulators.
* Perform root cause analysis on exam findings and work with appropriate business units on corrective action plans.
* Assist in the drafting of audit finding responses to regulators as required.
* Schedule/Facilitate meetings with regulators via Teams, Skype, Outlook, and onsite schedules.
* Provide assistance with regulatory reporting, including MBFRF, MCRs and other required reporting to state regulatory agencies.
* Provide assistance with weekly updates to compliance for deck presentations.
* Exam status reporting to management for dept.
* Maintain current daily exam status logs.
* Performs related duties as assigned by management.
* These essential functions are fundamental to the role, and must be performed on-site, as they cannot physically be performed remotely. In addition, the Company has determined that an in-person presence is important to critical components of our work, including oversight, training, collaboration, and productivity. Items not marked (*) as essential on-site, may still require partial on-site work to perform the role satisfactorily.
Education and Experience Requirements
* High school diploma or equivalent, required.
* 5+ years of experience, or combination of Compliance, Mortgage Servicing, Default Servicing, Debt Collections. IT Audit experience preferred.
* Experience in developing and delivering presentations to senior management.
* Experience in process definition and control definitions based on industry best practices.
Knowledge, Skill, and Ability Requirements
* Ability to multi-task as well as quickly adapt to changing work assignments.
* Knowledge of credit reporting and FCRA is a plus.
* Math and analytical skills needed.
* Ability to develop new, and maintain existing, business relationships in a complex cross-organizational and cross-functional matrix environment with both internal and external stakeholders)
* Working knowledge of risk management.
* Familiarity with Mortgage Servicing systems is preferred.
* Excellent work ethic and deadline driven.
* Follow up skills and a strong sense of accountability.
* Must possess a short learning curve related to assimilation of new skills and tasks.
* Superior organizational skills needed.
While this description is intended to be an accurate reflection of the position's requirements, it in no way implies/states that these are the only job responsibilities. Management reserves the right to modify, add or remove duties and request other duties, as necessary.
By applying to this position candidate acknowledges that this is not a remote role and is required to be on-site.
Additional Information:
While this description is intended to be an accurate reflection of the position's requirements, it in no way implies/states that these are the only job responsibilities. Management reserves the right to modify, add or remove duties and request other duties, as necessary.
All employees are required to have smart phones that meet Company security standards with the ability to install apps such as Okta Verify and Microsoft Authenticator. Employment will be contingent on this requirement.
Company Benefits:
Newrez is a great place to work but we are only as strong as our greatest asset, our employees, so we believe in rewarding them!
* Medical, dental, and vision insurance
* Health Savings Account with employer contribution
* 401(k) Retirement plan with employer match
* Paid Maternity Leave/Parental Bonding Leave
* Pet insurance
* Adoption Assistance
* Tuition reimbursement
* Employee Loan Program
* The Newrez Employee Emergency and Disaster Fund is a new program to support our team members
Newrez NOW:
* Our Corporate Social Responsibility program, Newrez NOW, empowers employees to become leaders in their communities through a robust program that includes volunteering, philanthropy, nonprofit grants, and more
* 1 Volunteer Time Off (VTO) day, company-paid volunteer day where all eligible employees may participate in a volunteer event with a nonprofit of their choice
* Employee Matching Gifts Program: We will match monetary employee donations to eligible non-profit organizations, dollar-for-dollar, up to $1,000 per employee
* Newrez Grants Program: Newrez hosts a giving portal where we provide employees an abundance of resources to search for an opportunity to donate their time or monetary contributions
Equal Employment Opportunity
We're proud to be an equal opportunity employer- and celebrate our employees' differences, including race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, and Veteran status. Different makes us better.
CA Privacy Policy
CA Notice at Collection
$55k-84k yearly est. Auto-Apply 52d ago
Financial and Regulatory Analyst
Centracare 4.6
Remote job
Find your purpose as a Financial and Regulatory Analyst at CentraCare. The Financial and Regulatory Policy Analyst serves as a cross-functional expert supporting financial analysis, payer policy review, and regulatory compliance. This role is responsible for evaluating the financial and operational impact of payer policies, government reimbursement regulations, and healthcare legislation. The analyst partners with managed care, revenue cycle, government reimbursement, compliance, and clinical operations teams to ensure alignment with payer requirements, optimize reimbursement, and mitigate regulatory risk.
Schedule:
Full-time 72 hours every 2 weeks
Hours between Monday - Friday 8:00a-5:00p CST
Fully remote
Pay and Benefits:
Starting pay begins at $63,747.33 per year and increases with experience.
Salary range: $63,747.33-$95,642.90 per year
Salary range is based on a 1.0 FTE, reduced FTE will result in a prorated offer rate
We offer a generous benefits package that includes medical, dental, flexible spending accounts, PTO, 401(k) retirement plan & match, LTD and STD, tuition reimbursement, discounts at local and national businesses and so much more!
Qualifications:
Bachelor's degree in Finance, Health Administration, Public Health, Economics, or related field or 5+ years of experience in financial analysis, strong report-building skills, payer relations, or regulatory affairs in a healthcare environment.
Understanding of Medicare and Medicaid payment systems, managed care contracts, and payer policies required.
Proficiency in Excel and financial modeling; ability to interpret large datasets required.
Familiarity with EHR and revenue systems (e.g., Epic, Lawson, Strata, or similar) preferred.
Experience with payer audits, prior authorization processes, and coverage policy review preferred.
Strong analytical, report creation, and critical thinking skills.
Clear written and verbal communication.
Regulatory and policy acumen.
Detail orientation with the ability to synthesize complex information.
Collaboration and stakeholder engagement
Core Functions:
Payer Policy & Regulatory Intelligence
Monitor and interpret payer policy updates, government reimbursement rules (e.g., Medicare, Medicaid, commercial plans), and legislation impacting financial performance.
Analyze changes in payer coverage determinations, billing guidelines, and authorization policies to assess impact on access, documentation, and reimbursement.
Collaborate with internal stakeholders to implement payer policy changes and ensure compliance across the revenue cycle and clinical departments.
Identify opportunities for revenue enhancement and cost reduction through proactive management of payer policies.
Financial Analysis & Forecasting
Build and maintain financial models to forecast the revenue impact of regulatory or payer policy changes.
Analyze variances in net revenue, denials, and reimbursement trends related to policy shifts and provide regular reports to the HealthCare Affordability Committee.
Support budget planning and value-based contract modeling by incorporating regulatory and policy data.
Develop metrics to track policy compliance, identify gaps, and propose solutions to improve processes and outcomes.
Document and communicate findings, recommendations, and action plans to the HealthCare Affordability Committee.
Regulatory Compliance & Reporting
Track regulatory requirements from CMS, state Medicaid agencies, and commercial payers.
Collaborate with compliance teams and revenue integrity teams to implement and maintain internal controls and audits to minimize risk.
Collaborate with payer relations to address any payer-policy-related issues.
Monitor adherence to payer policies across the organization.
Partner with clinical and operational teams to ensure policy changes are implemented efficiently and effectively.
Collaborate with the legal department to review and interpret contracts, agreements, and regulations.
Communicate effectively with payers to clarify policy details and resolve disputes.
Work closely with the revenue cycle management team to optimize claims processing and reimbursement.
Cross-Functional Collaboration
Act as a liaison between Finance, Compliance, Managed Care, Revenue Cycle, and Clinical Operations teams.
Analyze clinical vendor reimbursement assumptions.
Deliver policy summaries and financial impact briefs to operational leaders, with clear recommendations.
Support stakeholders on new or updated payer policies and regulatory requirements.
CentraCare has made a commitment to diversity in its workforce and all individuals, including, but not limited to, individuals with disabilities, are encouraged to apply. CentraCare is an EEO/AA employer.
$63.7k-95.6k yearly Auto-Apply 8d ago
Manager, Political Affairs
Edison Electric Institute 4.2
Remote job
WHO WE ARE
The Edison Electric Institute (EEI) is the association that represents all U.S. investor-owned electric companies. Our members provide electricity for more than 220 million Americans and operate in all 50 states and the District of Columbia. As a whole, the electric power industry supports more than 7 million jobs in communities across the United States.
EEI employees are required to work in office Monday-Thursday, and have the option to work remotely on Fridays.
KEY RESPONSIBILITIES OF THE MANAGER, POLITICAL AFFAIRS:
The Manager, Political and External Affairs plays a critical role in advancing EEI s federal political engagement strategy by supporting the Senior Director across three core areas: PAC fundraising, industry event management, and political programming.
The Manager serves as the internal lead for PowerPAC fundraising, driving engagement from member companies. The Manager collaborates closely with the PAC Steering Committee and EEI leadership to meet annual fundraising goals, manage the PowerPAC budget, track performance, and ensure full compliance with all reporting requirements. The Manager also produces treasurer s reports, maintains donor and disbursement records, and provides background materials to support contribution decision-making.
Other important responsibilities of the Manager, Political Affairs:
Support the Senior Director in executing PowerPAC s fundraising strategy, helping to engage all eligible groups and member companies to meet annual fundraising goals.
Assist in developing PAC campaigns, strengthening relationships, and identifying opportunities to expand PAC participation and visibility.
Assist in managing the PowerPAC budget, including tracking fundraising totals, monitoring financial activity, preparing candidate disbursements, and supporting PAC Steering Committee operations.
Prepare treasurer s reports and write detailed memos summarizing political background information, candidate assessments, and related analysis.
Play a central role in planning and executing EEI s major political and industry events, ensuring operational excellence and strategic alignment with EEI s advocacy objectives.
Provide operational, financial, and compliance support to the Senior Director, including processing invoices; coordinating with the General Counsel s office on contracts; and preparing materials for the semiannual LD-203 contributions report.
Administer the charitable PAC match program, ensuring accuracy and timely processing on behalf of EEI employees who contribute to PowerPAC.
REQUIRED & PREFERRED QUALIFICATIONS:
A bachelor s degree in Political Science, Communications, Public Policy, or a related field is required.
6-8 years of experience in PAC management, political fundraising, political operations, or planning high-level political or industry events is required.
Demonstrated ability to research, interpret, and analyze political trends and developments.
Exceptional written and verbal communication skills with experience drafting policy briefs, analytical reports, and background materials for senior leaders, elected officials, or policymakers.,
Strong technical and administrative skills, including proficiency with Office 365 and Microsoft Office applications, and the ability to learn internal accounting and budgeting systems.
Strong organizational skills and the ability to take initiative, manage competing priorities, and complete projects in a timely manner are essential.
Travel requirement: 10%.
COMPENSATION
The salary range for role is $80,000-125,000. Starting annual salary will be determined on individual qualifications. We offer a competitive benefits package that includes medical, dental, vision, 401k, paid time off, tuition assistance, wellness incentives and programs, transportation subsidy, and professional development opportunities. The role is eligible for a performance based bonus for the 2026 calendar year which is paid out the following March.
PHYSICAL AND SENSORY DEMANDS
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EEI is committed to providing a productive and safe environment. To achieve that goal, we conduct background and reference check investigations for all final applicants being considered for employment. Equal Opportunity Employment M/D/F/V.
$80k-125k yearly 41d ago
Regulatory Lead, Operator
The Wing 3.9
Remote job
About Wing:
Wing offers drone delivery as a safe, fast, and sustainable solution for last mile logistics. Consumer appetites for on-demand services are increasing, but current delivery methods are inefficient, costly, and contribute to road accidents and air pollution. Wing's fleet of highly automated delivery drones can transport small packages directly from businesses to homes on-demand, in minutes. We design, build, and operate our aircraft, and offer drone delivery services on two continents. Our technology is designed to be easy to integrate into existing delivery and logistics networks, offering a scalable drone delivery solution for a broad range of businesses. Wing is a part of Google's parent company, Alphabet, and our mission is to create the preferred means of delivery for the planet. If you're ready to do the greatest work of your life, come join us.
About the Role:
Wing is looking for an Regulatory Lead, Operator to join our Global Aviation Regulatory Team. This role is based remotely in the US and reports to the Global Aviation Regulatory Lead. You will be responsible for leading Wing's regulatory strategy for the development, approval, and sustainment of our operational authorizations worldwide. Additionally, the Aviation Regulatory Lead will play a key role in the deployment of operator-facing system changes, evolving procedures and training, and expansion of operational capabilities. The ideal candidate will bring a deep understanding of today's uncrewed aircraft systems operational regulations in the US and around the globe along with emergent rulemaking that may impact Wing's future operations. The successful candidate will utilize this knowledge and expertise to provide leadership for Wing's future operator regulatory compliance strategy. This position will work closely with the flight operations teams to ensure compliance with applicable regulations but also develop innovative approaches to support our drone delivery business case. This role requires excellent written and verbal communication skills and the ability to collaborate with cross-functional teams. Ideal candidates have a passion for aviation and technology and are eager to learn and search for solutions in a dynamic and constantly evolving environment.
What You'll Do:
Lead the development, submission, and defense of comprehensive Operating Safety Cases to secure operational authorizations (e.g., Air Operator Certificate for the US, Specific Category approvals in the UK and EU, etc.) and airspace access (e.g., BVLOS/airspace waivers, special flight authorizations) from aviation regulators worldwide.
Collaborate closely with other key engineering and operational stakeholders in the deployment of operator-facing system changes, evolving procedures and training, and expansion of operational capabilities.
Interface routinely with various stakeholders across the company to ensure that all stakeholders understand the evolving regulatory environment and its impact on Wing's activities.
Collaborate with other members of the aviation regulatory team supporting their respective functions for Wing's operations around the world.
Actively participate in the development of industry consensus standards related to the functional domain of expertise.
Proactively stay up-to-date with evolving regulations related to the functional domain of expertise, while developing and proposing alternative approaches to enable the company's innovative systems to keep on pioneering the drone delivery market.
What You'll Need:
Bachelor's degree in aviation, engineering,or a related field, or relevant technical experience. A Master's degree in aviation, engineering, or a related field is a plus.
Minimum 12+ years of experience in aviation regulatory affairs, or a similar role, with a strong focus on air carrier operations (e.g. Part 135) or advanced UAS/drone operations.
Proven track record of successfully securing and managing complex operational and airspace authorizations from major global aviation regulators (e.g., FAA Part 135, EASA/CASA/UK SORA, etc.).
Excellent communication and collaboration skills to work effectively with cross-functional teams, with the ability to articulate complex technical and regulatory concepts clearly to regulators and technical teams.
Startup mentality, resourceful and resilient with the ability to get things done in dynamic circumstances.
Ability to travel nationally and internationally (as needed).
The US base salary range for this full-time position is the salary range below + bonus + equity + benefits. Wing's salary ranges are determined by role, level, and location. Your recruiter can share more about the specific salary range for your location during the hiring process.
Salary Range$134,000-$259,000 USD
Wing is an equal opportunity employer and it is Wing's policy to comply with all applicable national, state and local laws pertaining to nondiscrimination and equal opportunity. Employment at Wing is based solely on a person's merit and qualifications directly related to professional competence. Wing does not discriminate against any employee or applicant because of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), or any other basis protected by law.
If you have a need that requires accommodation during the interview process due to a disability or special need, please let us know by completing our Candidate Accommodations Request Form.
$37k-70k yearly est. Auto-Apply 3d ago
Regulatory Labeling Analyst I
Covestro
Remote job
Under the direction of the Senior Manager, Trade Compliance, the Regulatory Labeling Analyst supports regulatory compliance activities related to Covetrus North America's growing portfolio of private brand products, including the development, review, and approval of the company's private brand product labeling and product registration.
This position ensures Covetrus North America's private brand product labeling is compliant with federal and state regulations (e.g., FDA, DEA, and state laws and regulations).
The Regulatory Labeling Analyst I will communicate with both internal and external stakeholders throughout the labeling process for both new label and labeling updates as well as product registration and renewals.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned.
Review and approve product packaging and labeling to ensure it meets Covetrus brand and regulatory standards.
Support lifecycle management for prescribing information, patient labeling, and packaging artwork, in accordance with Covetrus SOPs.
Maintain awareness and understanding of industry-standard labeling practices as well as FDA, DEA, and state labeling regulations.
Develop and maintain a thorough understanding of Covetrus policies and FDA regulations for animal health product labeling.
Stay up to date on any changes to labeling regulations and communicate changes to relevant departments.
As assigned by the Regulatory Labeling Program Supervisor, attend team and status update meetings in support of product launches, artwork revisions, and other labeling needs, and report findings back to the Regulatory Labeling team.
Practice active communication with cross-functional teams to keep others informed of project status.
Manage labeling artwork pieces in line with existing change management processes.
Perform regular drug listing auditing to ensure the accuracy of Covetrus private brand labels on file with regulatory bodies.
Develop and maintain an understanding of different supplier processes and methods for product labeling in order to ensure product labeling is accurate to artwork files and Covetrus standards.
Communicate artwork revisions and approvals in a timely manner to keep product launches and updates on schedule.
Build sustainable relationships of trust through open and interactive communication with both internal and external customers.
Support team members across Quality & Regulatory Affairs with investigations and research related to Covetrus' private brand product labeling and/or product registration requirements, as assigned.
Inspect their own work critically and communicate any errors, issues, and/or concerns to the Regulatory Labeling Program Manager.
Assist with collecting and tracking metrics related to labeling.
Escalate issues pertaining to Regulatory Labeling, including internal and external customer complaints, to the Regulatory Labeling Program Manager.
Perform additional duties as assigned.
QUALIFICATIONS:
EDUCATION AND/OR EXPERIENCE
Associate's Degree (preferred) or equivalent industry experience and proven track record in job related tasks.
Minimum of 0-2 years of related industry experience with exposure to a regulatory, law enforcement, and/or security environment or combination of equivalent education and experience
CERTIFICATES, LICENSES, REGISTRATIONS (Preferred not required)
Certified Pharmacy Technician or Certified Veterinary Technician
COMPETENCIES (SKILLS AND ABILITIES)
Customer/Client minded.
Ethical conduct.
Research skills.
Experience with Microsoft Office tools and various project management tools. Proficient in designer software and technologies (such as Adobe InDesign, Illustrator, and Photoshop) preferred.
Experience with project management tools (e.g., Asana and Smartsheet)
Experience with Salesforce and/or Quality Management Systems
Reading comprehension - ability to understand written sentences and paragraphs in work-related documents. Ability to comprehend basic principles, theories and laws, policies, and procedures that pertain to wholesale drug distribution. Ability to follow SOPs.
Critical thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. Ability to pay attention to details.
Mathematics - using mathematics to solve problems.
Technical- proficient on keyboard and operating a computer terminal with multiple software systems.
Communication - ability to communicate both verbally and in written format in a professional manner.
Adaptability- the ability to adapt to changing situations and perform under tight timelines.
Dependability - exhibit punctuality and low absenteeism.
Ability to multitask and prioritize tasks in a fast-paced environment meeting or exceeding SLA and established metrics for the assigned tasks.
PHYSICAL DEMANDS/WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
Pet-friendly environment
Extensive computer work
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:
401k savings & company match
Paid time off
Paid holidays
Maternity leave
Parental leave
Military leave
Other leaves of absence
Health, dental, and vision benefits
Health savings accounts
Flexible spending accounts
Life & disability benefits
Identity theft protection
Pet insurance
Certain positions may include eligibility for a short-term incentive plan
Salary may vary depending on factors such as confirmed job-related skills, experience, and location. It is not typical for an individual to be hired at or near the top end of the range for their role. Compensation decisions are dependent upon the facts and circumstances of each case.
Sales Positions are eligible for a Variable Incentive.
The pay range for this position is as follows:
$46,400-$61,800
Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
$46.4k-61.8k yearly Auto-Apply 38d ago
Specialist, Regulatory Operations
Care Access 4.3
Remote job
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference Care Access is seeking a skilled and experienced Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department. The Specialist, Regulatory Operations will oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. They may also support regulatory activities for Canadian sites as needed. This role is responsible for ensuring compliance with applicable U.S. regulations and guidelines and may contribute to site start-up activities for U.S. sites when required. You will have a good understanding of U.S. regulatory requirements and experience supporting regulatory activities for clinical research sites. How You'll Make An Impact
Study-specific regulatory operations:
Act as main regulatory operations contact for assigned studies
Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, -OHRP and global regulatory standards.
Coordinates preparation and review of key site essential records.
Assist in preparing for sponsor monitoring visits and follow up requirements, ensuring compliance and --readiness for assigned studies.
Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices.
Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
Track essential records and timelines
Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout.
Actively work towards KPIs to help ensure departmental success
Supports creation and maintenance of study Delegation of Authority (DOA) logs
Support regulatory activities throughout the duration of the study life cycle; collaborating with clinical operations teams to ensure regulatory compliance
Coordinate and perform IRB site level submissions and maintenance of approvals throughout the life of the study.
Review, and submit high-quality and timely IRB submission materials, including but not limited to protocols, ICFs and marketing materials.
Reviews and customize, when required, ICFs to ensure compliance with U.S. IRB requirements and site feedback.
Liaise and follow up directly with Sponsor.
Ensures accurate compilation, management and tracking of submissions.
Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness Ensure timely filing of safety reports, deviations, and amendments/modifications as per study requirements.
Ensures that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with Good Clinical Practice (GCP), regulatory requirements and internal processes.
Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents for regulatory inspections and sponsor audits.
Milestones: Tracks and updates the study team accordingly
Other Responsibilities
Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met.
Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
Ability to communicate and work effectively with a diverse team of professionals
Communication Skills: Good verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
Good computer skills with demonstrated abilities using clinical trials database, MS word and excel
Experience in electronics Investigator Site Files systems like (Florence, CRIO)
Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
High level of self-motivation and energy
Ability to work independently in a fast-paced environment with supervision
Must have a client service mentality
Demonstrated success in managing IRB submissions
Detail-oriented with good problem-solving abilities and a proactive approach to regulatory challenges
Ability to handle multiple tasks in a fast-paced and constantly changing environment.
Certifications/Licenses, Education, and Experience:
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience
Minimum of 2 years of experience in operational regulatory affairs within theresearch site (preferable), or -CRO/pharmaceutical industry.
Understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
Good knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S.
Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance.
How We Work Together
Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$60k-88k yearly est. Auto-Apply 2d ago
Sr. Regulatory Professional
Agilent Technologies 4.8
Remote job
This is an exciting opportunity to be part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to laboratories, partners, and patients globally. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.
In the Companion Diagnostics Business (CDx), our team partners with leading pharmaceutical companies to develop, manufacture, and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.
As the Regulatory Companion Diagnostics Professional, you will ensure compliance to medical device and CDx IVD regulations globally. In conjunction with other groups in Global Regulatory Affairs, the CDx Regulatory Affairs Department communicates with worldwide health authorities in the licensing of all products in development or currently marketed globally. The Regulatory Professional integrates broad business concepts and strategies into structured projects leading design and delivery of new products and solutions as a key technical contributor. The ability to tackle complex, high-impact project design problems is required.
Main Responsibilities
Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
Compiles materials required in submissions, license renewal, and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort, and identifies and mitigates areas of risk.
Reviews product labeling and marketing materials for accuracy and compliance with regulations.
Response to customers and/or authorities' requests/inquiries dealing with regulations and product compliance.
Represents the company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
May assess requirements and identify strategies for the earliest possible approvals of clinical trials applications.
Determines and develops approaches to assignments.
Leads regulatory projects requiring coordination with other functions, third parties.
Solves a broad range of problems of varying scope and complexity.
Qualifications
Bachelor's or Master's Degree or equivalent
8+ years relevant experience for entry to this level.
Possess proven experience in a similar role.
Requires in-depth knowledge and experience in the job and the ability to work independently.
Additional Details
This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least January 29, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $124,160.00 - $207,580.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory
$124.2k-207.6k yearly Auto-Apply 8d ago
Regulatory Analyst II
GCI Communication Corp 4.7
Remote job
GCI's Regulatory Analyst II will create, implement, and ensure GCI's compliance with regulations. Prepare monthly carrier access billings and pool/settlement reporting; monitor and maintain access minute reporting functions; prepare, maintain, and interface with regulatory agencies filings for state and interstate tariffs, rate postings, Federal Universal Service Fund, and the Alaska Universal Service Fund; assist in preparation of cost studies and network use analyses; perform other regulatory/financial work. Keep appraising any regulation changes on both the state and federal side and offer interpretation. Prepare company tariffs and rate postings under both federal and state regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES AT ALL LEVELS:
Regulatory Filing Preparation and Analysis:
Read and interpret FCC, RCA, and other regulatory entity rules, regulations, and procedures. Analyze and offer recommendations in response to any upcoming regulatory issues. Seek out, notify, and coordinate with other personnel within the organization to ensure process creation and ongoing compliance. Prepare reports and filings with regulatory bodies to ensure accurate receipt of Universal Service fund support and pooled earnings. Create processes, interpret changes, and maintain accurate documentation regarding each filing and the regulation or rule driving it.
Tariff/Posting Preparation:
Audit, preparation and filing of access tariffs as well as tariff interpretations and quotes; maintenance of local and long-distance rate postings, terms, and conditions. Coordination with other departments to maintain compliance. Streamline and automated processes where necessary.
Access Minute Management:
Act as first point of contact for Local Exchange Carrier (LEC) CABs preparers. Manage trunk tables to ensure accurate access minutes are being captured and review monthly files sent to LECs. Work closely with IT Analysis to ensure data integrity. Calculate quarterly billing factors and maintain records sufficient for audit.
Carrier Access Billing (CABs):
Prepare monthly CABS billing and related analysis. Use reports from the CABs system as needed to analyze trends and monitor the integrity of the CABs bill. Follow-up and resolve any trend analysis anomalies. Reconcile and balance billing reports used for Connect America Fund (CAF) filings. File Network Access Fee (NAF) revenues, Intrastate minutes of use, and switched circuits in the Alaska Exchange Carriers Association (AECA) portal.
COMPETENCIES:
+ ACCOUNTABILITY- Takes ownership for actions, decisions, and results; openly accepts feedback and demonstrates a willingness to improve.
+ BASIC PRINCIPLES - Interacts with people in a way that builds mutual trust, confidence, and respect; adheres to GCI's Code of Conduct for Employees - the Basic Principles.
+ COLLABORATION - Works effectively with others to accomplish common goals and objectives; maintains positive relationships even under difficult circumstances.
+ COMMUNICATION- Conveys thoughts and expresses ideas appropriately and professionally.
+ Ability to accurately communicate information virtually (i.e., Teams), over the phone, and in-person in a clear and concise manner to a range of audiences.
+ Ability to accurately read, write, and respond to business correspondence such as emails, chat messages, policies, procedures, reports.
+ Ability to multitask in a faced paced environment with successful results.
+ COMPLIANCE - Follows internal controls; protects confidential information; abides by GCI's Code of Business Conduct & Ethics.
+ CUSTOMER FOCUS - Demonstrates commitment to service excellence; gives high priority to customer satisfaction.
+ RELIABILITY - Consistently follows through on assigned tasks as expected; demonstrates timely attendance at meetings, training, and other work obligations.
+ RESULTS - Uses a combination of job knowledge, initiative, sound decision making, innovation, adaptability, and problem solving.
+ SAFETY & SECURITY - Supports a safe work environment by following all workplace safety rules and guidelines; complies with applicable Security policies and procedures.
+ TECHNICAL PROFICIENCY - Proficient computer skills and MS Office knowledge (e.g., Outlook, Teams, Word, Excel) to complete job duties effectively, such as using the company intranet and to accurately retrieve and input information into database or equivalents.
Additional Job Requirements:
Intermediate level analyst position. Must have a comprehensive understanding of telecommunications, and ability to follow documented procedures with no supervision. Works under moderate supervision and supports team. Requires ability to execute complex procedures. High degree of self-initiative and be able to prioritize and handle multiple tasks with independent decision-making. Individual must lead team members and effectively communicate directions.
Minimum Qualifications:
Required: *A combination of relevant work experience and/or education sufficient to perform the duties of the job may substitute to meet the total years required on a year-for-year basis
+ High School diploma or equivalent.
+ Bachelor's Degree in business administration, Finance, Economics, or related field.*
+ Minimum six (6) years of increasing responsibility in regulatory, compliance or related regulated industry experience. *
Preferred:
+ Four (4) years of experience working in the telecommunications industry for mid- to large-size private business.
+ Other relevant telecom industry or job specific certifications.
DRIVING REQUIREMENTS:
+ This position may require access to reliable transportation for occasional travel between retail store locations, offices, worksites, or other locations as needed.
PHYSICAL REQUIREMENTS and WORKING CONDITIONS:
+ Work is primarily sedentary, requiring daily routine computer usage.
+ Ability to work shifts as assigned, work in standard office/home office setting, and operate standard office equipment.
+ Ability to accurately communicate information and ideas to others effectively.
+ Physical agility and effort sufficiently to perform job duties safely and effectively.
+ Ability to make valid judgments and decisions.
+ Available to work additional time on weekends, holidays, before or after normal work hours when necessary.
+ Must work well in a team environment and be able to work with a diverse group of people and customers.
+ Virtual workers must comply with remote work policies and agreements.
The company and its subsidiaries operate in a 24/7 environment providing critical services to Alaskans and may need to respond to public health and safety matters or other business emergencies. Due to business needs employees may be contacted outside of the core business hours to respond to the immediate emergency. As such, you will be requested to provide emergency after-hour contact numbers, to include your home and cell phone numbers if you have those services.
Culture, Engagement, and Connection: At GCI, we foster an environment where the unique perspectives of our employees, customers, and fellow Alaskans are celebrated. We add value to our community by nurturing and empowering each member of our workforce, ensuring equal opportunities for every Trailblazer.
EEO: GCI is an equal opportunity employer. Qualified applicants are considered for employment without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, mental or physical disability, veteran status, or any other status or classification protected under applicable state or federal law.
DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
All employees of GCI work in support of the GCI Mission Statement and Declaration of Principles which are located on the GCI Career page and Employee portal.
$53k-65k yearly est. 41d ago
Learn more about regulatory affairs associate jobs