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  • Remote Regulatory Affairs Consultant (Strategy)

    Pharmatech Associates 3.6company rating

    Remote regulatory affairs specialist 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. 4d ago
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  • Remote Regulatory Affairs Manager - Global Submissions Lead

    Crinetics Pharmaceuticals, Inc. 3.9company rating

    Remote regulatory affairs specialist job

    A leading pharmaceutical company in San Diego is seeking a Regulatory Affairs Manager to oversee regulatory strategies for their development programs. You will work with cross-functional teams to ensure timely submissions and maintain regulatory compliance. The position requires a scientific degree and substantial experience in in relevant regulatory affairs. Benefits include competitive salary and health insurance. #J-18808-Ljbffr
    $85k-126k yearly est. 2d ago
  • Regulatory & Government Affairs Counsel - Remote

    Point 4.2company rating

    Remote regulatory affairs specialist job

    A financial services company based in Palo Alto is looking for an experienced Associate General Counsel to support regulatory compliance and government relations. The successful candidate will have a J.D., be eligible for in-house practice, and possess 4-7 years of relevant experience. Responsibilities include managing regulatory frameworks, collaborating with legislative representatives, and advocating for consumer finance standards. This role is remote-first, allowing flexibility while contributing to a mission-driven culture. #J-18808-Ljbffr
    $98k-145k yearly est. 3d ago
  • Remote Chief Compliance Officer - Global Platform Architect

    Allocator One Group

    Remote regulatory affairs specialist job

    A global investing platform is seeking a Compliance Chief Officer to design and implement a comprehensive regulatory operating system. You will lead SEC registration and ensure ongoing compliance while advising on fund structuring decisions. The ideal candidate brings over 7 years of experience in compliance at investment firms and possesses knowledge of SEC regulations. The position offers significant equity potential and is primarily remote with a preference for candidates in US time zones. #J-18808-Ljbffr
    $92k-153k yearly est. 4d ago
  • Telemedicine PMR - California License

    Vivo Healthstaff

    Remote regulatory affairs specialist job

    Vivo HealthStaff is actively recruiting a Telemedicine Physician for a long-term locum tenens position with a leading physical medicine clinic based in California. This fully remote opportunity enables physicians to provide critical care for patients without the need for in-person visits, offering flexibility while supporting a specialized medical practice. The Telemedicine Physician will play a crucial role in managing cases related to Traumatic Brain Injury (TBI) and personal injury assessments. **Position Details:** In this role, physicians will work between 2 to 5 days per week, partnering with a physical medicine and rehabilitation (PMR) clinic dedicated to providing high-quality care to patients dealing with TBI and other injuries. Your responsibilities will primarily include conducting virtual examinations for TBI assessments, personal injury cases, and other related medical conditions. This is an ideal role for physicians interested in long-term telemedicine work and building continuity with patients remotely. **Benefits:** - Competitive hourly rate - Weekly payments via direct deposit - Medical malpractice coverage provided - Completely digital onboarding process for quick and easy setup **Requirements:** - Active and unrestricted California Medical License - Active and unrestricted DEA license - Board eligibility or certification in one of the following: - Preventive Medicine - Occupational Medicine - Physical Medicine and Rehabilitation - Pain Management - Neurology
    $50k-88k yearly est. 6d ago
  • US Regulatory Affairs Specialist

    Henry Schein 4.8company rating

    Remote regulatory affairs specialist 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 21d ago
  • Senior Regulatory Affairs Specialist (Remote - United States)

    Healthcare Services 4.1company rating

    Remote regulatory affairs specialist 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 $131,750 - $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, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.
    $131.8k-170.5k yearly Auto-Apply 6d ago
  • Senior Regulatory Affairs Specialist (Remote - United States)

    Solventum

    Remote regulatory affairs specialist 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 $131,750 - $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, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.
    $131.8k-170.5k yearly Auto-Apply 6d ago
  • Remote Regulatory Affairs Specialist

    Actalent

    Remote regulatory affairs specialist job

    We are seeking a skilled Regulatory Affairs Specialist to join our dynamic team. Responsibilities * Support the team in managing state regulatory activities to obtain and maintain registrations, including FIFRA Sections 3, 24c, 2ee, 18, and 5 for crop protection products. * Communicate with state regulatory agencies regarding submissions, approvals, renewals, and other related matters. * Maintain and update regulatory databases and other internal tracking systems. * Scan regulatory mail and other supporting documents and file them electronically. * Track and process payment of state registration fees, including new product registration fees, annual state renewal fees, and tonnage fees. * Review product labels for accuracy and consistency. * Maintain compliance by interpreting and evaluating federal and state registration requirements as they apply to our products. * Provide regulatory support and service to both internal and external stakeholders. * Respond to inquiries for regulatory information from internal and external stakeholders. * Scan regulatory and supporting documents and file them in databases or mail them to designated recipients. * Complete other assignments as required. Essential Skills * Bachelor's degree in a field of science, business, or a related discipline plus 2 years of professional working experience. * Strong attention to detail. * Highly developed written and oral communication skills. * Proficiency in the Microsoft Office suite. * Database management experience. * Strong problem-solving skills. * Ability to multitask and manage multiple projects. * Ability to work independently and in a team environment. Additional Skills & Qualifications * Experience with document comparison tools is a plus. Job Type & Location This is a Contract position based out of Chicago, IL. Pay and Benefits The pay range for this position is $36.00 - $36.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Chicago,IL. Application Deadline This position is anticipated to close on Jan 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $36-36 hourly 3d ago
  • Exam Coordinator III- Regulatory Mortgage

    Newrez

    Remote regulatory affairs specialist 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 41d ago
  • Exam Coordinator III- Regulatory Mortgage

    Newrez LLC

    Remote regulatory affairs specialist 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 42d ago
  • Senior Licensing & Regulatory Coordinator

    Jubilant Bhartia Group

    Remote regulatory affairs specialist job

    Join a team where precision meets purpose. At Jubilant Radiopharma, we're advancing healthcare through innovation-and we need detail-driven professionals to help us stay compliant and operational. If you have a paralegal background and thrive on organization, accuracy, and problem-solving, this role is for you. About the Role As a Licensing & Regulatory Coordinator, you'll be the backbone of our compliance efforts, ensuring all federal, state, and local permits, licenses, and registrations are maintained without interruption. You'll research, draft, edit, and file critical documents, track renewal timelines, and keep our regulatory framework strong and reliable. What You'll Do * Partner with operations and regulatory teams to maintain and update licenses, permits, and registrations, including timely fee payments. * Serve as a trusted advisor by understanding business goals and aligning compliance strategies to support them. * Prepare filings, manage document workflows, and maintain accurate historical records of all licensing activities. * Handle multiple priorities with strong planning and analytical skills, leveraging technology for efficiency. * Respond to inquiries and provide guidance on operating policies to ensure consistency and compliance. * Participate in meetings to stay ahead of new requirements and regulatory changes. * Perform additional duties as needed to support smooth operations. What You Bring * Bachelor's degree in Business or related field (or equivalent experience). * 2-4 years in regulatory, compliance, or licensing roles-pharmaceutical or radiopharmacy experience preferred. * Advanced proficiency in Microsoft Office and online research tools; SAP experience is a plus. * Exceptional organizational skills, attention to detail, and ability to manage multiple deadlines. * Strong written and verbal communication skills. * Collaborative, customer-focused mindset. * Experience with pharmacy or radiopharmacy licensing is highly valued. Why Jubilant Radiopharma? * Be part of a mission-driven organization improving patient care worldwide. * Work in an inclusive, supportive environment that values diverse perspectives. * Opportunities for growth and professional development. Ready to make an impact? Apply today and help us keep healthcare moving forward. Candidates whose experience matches what Jubilant Radiopharma is seeking will be contacted directly for an interview. If candidates need assistance in applying for this position, please call ************. Candidates must successfully complete pre-employment drug screen and criminal background check. Individuals with Disabilities/Protected Veteran are welcomed. Thank you for your interest in joining the Jubilant Radiopharma team!
    $58k-84k yearly est. 25d ago
  • Sr. Regulatory Affairs Specialist - REMOTE

    Jobgether

    Remote regulatory affairs specialist job

    This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Regulatory Affairs Specialist. In this role, you will support the development and implementation of long-range regulatory strategies that impact the introduction of new products and the compliance of existing ones. Your leadership will guide regulatory staff, ensuring all products meet U.S. and international standards. You will be a key player in compliance activities and bear significant responsibility in product development and modifications.Accountabilities Maintain current knowledge of applicable laws and regulations. Interpret regulatory requirements for products and ensure compliance. Participate as a regulatory representative on project teams. Lead submission activities for device clearances/approvals. Review change orders and assess regulatory impact. Oversee labeling, training, and promotional material compliance. Represent the organization in working groups related to regulatory objectives. Support due diligence and post-acquisition assessments. Develop and implement regulatory education and training. Assist in policy and procedure development within the department. Requirements Bachelor's Degree with 7+ years in regulatory affairs or relevant field. Medical device experience is required. Experience with 510(k) or PMA submissions for FDA. Knowledge of U.S. and EU regulations for medical devices. Excellent communication and presentation skills. Ability to manage multiple projects with attention to detail. Proficiency in MS Word, Excel, and PowerPoint. Benefits Competitive salary and flexible benefits package. Health, Dental, and Vision insurance. 401(k) plan with employer match. Paid time off and holidays. Tuition assistance and reimbursement. Employee Stock Purchase Plan. Short-term disability and life insurance. Employee Assistance Program. Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.#LI-CL1We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $58k-85k yearly est. Auto-Apply 5d ago
  • Regulatory Lead, Operator

    The Wing 3.9company rating

    Remote regulatory affairs specialist 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 5d ago
  • Regulatory Affairs Coordinator - Cancer Center Compliance (Remote)

    Mayo Clinic 4.8company rating

    Remote regulatory affairs specialist job

    Responsible for planning and implementation of compliance activities associated with the protection of human subjects and investigational use of agents (drugs, biologics, device, etc.). Monitors the internal and external regulatory environment to promote centralized, coordinated, and proactive identification, development, and implementation of new or revised policies, procedures, etc. applicable to MCCC research programs. Researches relevant regulatory issues and evaluates the adequacy and effectiveness of compliance processes and controls related to Mayo Clinic Cancer Center (MCCC) research programs. Proposes compliance-enhancing recommendations to MCCC leadership and facilitates the development and implementation of new or revised MCCC policies and procedures pertaining to human research protections and the investigational use of agents. Through these activities, facilitates, the compliance of MCCC research programs with Mayo Foundation and National Cancer Institute (NCI) policies, and U.S. and foreign government regulations, including those of the U.S. Food and Drug Administration, Health Canada, and other equivalent agencies. Participates in other compliance-related administrative activities including development and delivery of educational programs, and assistance, as necessary, during select external audits and site visits (i.e., FDA, and NCI or other sponsors). Serves as a resource concerning policies, procedures, and regulations applicable to MCCC research programs. Represents the MCCC research programs from a regulatory perspective in national forums/venues. Presentations at meetings or other conferences, seminars, and classes, and occasional travel may be required. Manages the submission and ongoing maintenance of U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications, Health Canada Clinical Trials Applications (CTAs), and other equivalent activities as may be applicable to the research programs of the MCCC. Supports the MCCC Protocol Review and Monitoring System (PRMS), and the MCCC Clinical Research Office, and promotes efficiency and adaptability through the coordinated development and maintenance of policies, working instructions, standard operating procedures, protocol templates, etc., related to the protection of human subjects and investigational use of agents (drugs, biologics, etc.). May have direct supervisory responsibilities. A bachelor's degree (BA,BS) and a minimum of 5 years' experience in compliance, quality management, audit, or other relevant healthcare experience is required. Typical duration of prior experience is 5-10 years. Knowledge and experience in the interpretation and application of laws and regulations relating to human subjects' research protections and investigational use of agents (drugs, biologics, etc.) are required. Exceptional human relations skills and excellent communication skills (written, verbal, and listening) are required. Organizational project management skills are essential. Should have an inquiring, analytical and persistent disposition to enable the asking of follow-up questions that might not occur to others and look deeply into each area of concern. Collaborates with management in identifying improvement opportunities and developing corresponding solutions. Must be flexible and capable of adapting to and facilitating change. Must be very detail oriented. Must have the ability to work independently and productively with a minimum of direction and to routinely exercise initiative and sound judgment. Must possess effective leadership and management qualities, including the ability to motivate and to influence others. Compliance issues may create difficult situations for the involved individuals. Therefore, fairness in approach is essential. Objective and dispassionate interest in issues must be maintained, while maintaining mutual respect for individuals. Computer literacy and medical terminology are essential. Must be efficient in the use of personal computers for word processing, spreadsheets, data analysis, creation of graphs and charts, presentations, electronic communications, and research. Must have demonstrated the capacity to comprehend complex structures and connections. The ability to exercise good judgment in ambiguous situations while under pressure; strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities. A strong understanding of FDA regulations and proficiency in medical terminology is preferred. The following certifications are preferred: Cert Clinical Res Professional (CCRP), Cert Clinical Research Assoc (CCRA), Certified Clinical Research Co (CCRC) and Regulatory Affairs Certificate (RAC) and Certified IRB Professional (CIP). Note: Visa sponsorship is not available for this position. Must be a U.S. citizen, permanent resident, refugee or asylee.
    $74k-123k yearly est. Auto-Apply 3d ago
  • Financial and Regulatory Analyst

    Centracare 4.6company rating

    Remote regulatory affairs specialist 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 31d ago
  • Sr. Regulatory Affairs Specialist, Wound Closure - Remote

    Corza Medical

    Remote regulatory affairs specialist job

    **Our mission** At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way. **Our brand promise** We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price. + **Remarkable service:** A seamless, personal process designed around you and your needs. + **Trusted performance:** Our product family is the result of years of experience championing surgeons and listening to their expertise. + **Outstanding value:** No matter the surgical specialty, we deliver quality products for all markets. **Our people promise** Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do. **Job Purpose Summary** The Senior RA Specialist position is responsible for preparing regulatory submissions and registration documentation, providing quality and timely regulatory support to obtain marketing clearance/approval for new products and maintaining marketability of existing products. **What you will do** + Assist in the implementation of company's domestic and international regulatory submission strategies. + Manage multiple concurrent projects, balancing competing priorities and deadlines. + Develop and maintain submission trackers, readiness matrices, and compliance checklists to ensure operational efficiency. + Troubleshoot regulatory challenges and provide practical solutions to keep projects on track. + Provide mentorship and guidance to junior RA staff, fostering professional growth and team collaboration. + Review critical documents to assure completeness, and with supervision, will prepare responses to routine in-country representative or regulatory agency results. + Ensure the content, organization and overall quality of all regulatory documentation are adequate and sufficient to comply with local, regional and / or international regulatory requirements, commitments and agreements. + Development of tracking documents and follow-up to assure submissions are managed appropriately. + Perform the coordination and preparation of document package for regulatory submissions (US and international). + Compile all materials required in submissions, license renewal and annual registrations. + Keep abreast of regulatory procedures and changes. May have direct interaction with regulatory agencies on defined matters. + Represent regulatory affairs on project teams. + Develop and recommend strategies for earliest possible approvals of device applications. + Generate departmental procedures. + Ensure documents are apostilled, certified and legalized or notarized, as required. + Assess new and / or modified standards, regulations and / or laws and determine applicability to the organization and / or product. + Complete other related duties as required. + Conduct oneself consistent with company standards at all times during work hours or when acting as a representative of the company. **What you will need** + Bachelor's degree in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology, Chemistry or related field. + Minimum 5 years of experience in Regulatory Affairs in the medical device industry. + Experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America. + Experience with medical device regulations (21 CFR, MDR, MDSAP, ISO 13485) and Biologics License Applications (21 CFR) preferred. + Demonstrated success managing multiple projects and competing priorities in a fast-paced environment. + Experience mentoring or supervising junior staff. + Experience with Wound Care products preferred. + Experience in Quality Assurance or Quality Systems is strongly preferred. + Ability to communicate effectively both verbally and written. Effective and influential when working on teams, with solid negotiation skills when required to reach optimal decisions. + Ability to work on multiple scenarios of diverse scope where analysis of a situation or data requires evaluation of various factors. + Detail oriented with the ability to accomplish objectives with minimal supervision. + Travel Requirements - 15%+ In order to qualify for this position, applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time. **Key Attributes** + **Resilient multitasker** - thrives under pressure and adapts quickly to shifting priorities. + **Strategic communicator** - able to translate regulatory complexity into clear, actionable guidance. + **Collaborative leader** - balances hands-on execution with team development. + **Detail-oriented executor** - ensures accuracy and compliance while meeting deadlines. **What we value** + **Customer First** - We deliver extraordinary experiences. + **Accountability** - We do what we say. + **Integrity** - We do what is right. + **Inspired** - We love what we do. + **One Global Team** -We before me, always. Join us today and **Excel@Corza** ! **_Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits._** **_A reasonable estimate of the current pay range for this role is $100,000-$108,000/year. Further, pay is offered based on geographic location, internal equity, market data, applicant's job-related skills, commensurate experience, required licensures, certifications, and certain degrees._** **_Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics._** **_Notice To Third Party Agencies:_** **_Corza does not accept unsolicited resumes from recruiters, employment agencies, or other staffing services. Any unsolicited resumes, including those submitted to hiring managers or other business leaders, will become the property of Corza Medical and Corza Medical will have the right to hire that candidate without reservation - no fee or other compensation will be owed or paid to the recruiter, employment agency, or other staffing service._**
    $100k-108k yearly 11d ago
  • Entry Level Chemical Regulatory Analyst (Remote)

    Environmental Science 3.7company rating

    Remote regulatory affairs specialist job

    Shift: Monday through Friday, 8:00AM - 5:00PM 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. Make an impact. Build a career. At Pace , everything we do is built upon an unwavering commitment to making the world a safer, healthier place. We continually work to develop innovative practices that drive sustainability and empower our partners with accurate, quality data at every critical moment and milestone. That's why we need you - your curiosity, your talents, and your drive - to help us advance this important work, and your career. Find your place at Pace Join us as a Regulatory Analyst, where you'll put your love of science to work in the Scientific Insourcing Services department. You'll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace . This candidate will work with vendors to seek out chemical information in an entry-level regulatory services position. This is a great entry-level position to learn global chemical regulations for a wide range of materials. This is a non-laboratory position. Compensation: $20.00 per hour NOTE: Remote position What you'll do: Input information from vendor safety data sheets into a hazard communication database Review global chemical regulations and determine their application for various products Search for SDS sheets of raw materials Fill in missing or incorrect information in the SDS sheets Contact vendors as needed What you'll bring: Bachelor's degree in Biology, Chemistry, Biochemistry, or related science. Experience with Microsoft Office Ability to learn new computer software Customer service experience preferred 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.
    $20 hourly Auto-Apply 3d ago
  • Admnr Regulatory Sr - 006893

    EOG Resources 4.9company rating

    Regulatory affairs specialist job in New Albany, OH

    Duties will include but not be limited to preparation and submittal of oil and gas regulatory applications and notices of work, including the ability to permit special projects with minimal direction/supervision; coordination with Division personnel to secure data required for regulatory filings required by OH Regulatory agencies. Prepare and file state and federal Class II/VI UIC applications where applicable. Work with local, State and Federal regulatory agencies to obtain appropriate approvals and provide necessary information to the same in order to comply with the regulatory requirements of the associated project. Maintain various spreadsheets and files to facilitate tracking the regulatory process for reporting to management.
    $65k-83k yearly est. 11d ago
  • Regulatory Analyst II

    GCI Communication Corp 4.7company rating

    Remote regulatory affairs specialist 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. 30d ago

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