Regulatory Compliance Specialist jobs at Johnson & Johnson - 195 jobs

For over 90 years, Gold Medal has been a leader in the concession industry for both equipment and supplies including popcorn, cotton candy, Sno-Kones and much more. Gold Medal is a family-owned business with an excellent culture. We are proud to have been awarded the Best Place to Work in Cincy Magazine's 2020 Manny Awards. Due to our continued growth, we are excited to announce a Regulatory Document Compliance Specialist opportunity available at our Cincinnati location. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Food Labeling: 1. Develops and maintain accurate food labeling information for finished products compliant with FDA and USDA regulations. 2. Ensures that all on label claims are substantiated and that certifications and allergens are properly documented. 3. Provides technical guidance and addresses compliance related questions involving existing, new and reformulated products. · Business Engagement: 1. Actively participates in cross functional meetings that support product change/innovation. 2. Supports process improvement and label policy changes 3. Effectively communicates technical reasoning through research and make appropriate recommendations. 4. Collaborates with Legal, Product Development, Quality Assurance, Government Agencies, Supply Chain Vendors, and external trade associations. · International Support: 1. Generates documentation required to support international export markets engaging with USDA, APHIS, AMS and FDA. · Other Compliance: 1. Conducts technical reviews, both ingredient and recipe, for products sold domestically and internationally. 2. Has a working knowledge of International Food Additive and Food Labeling regulations to support regulatory review and compliance processes as needed. 3. Knowledge to maintain certification programs (Kosher, Halal). 4. Obtains and maintains current specifications for Raw Material, Packaging, Finished Goods and Re-sale products for the Approved Supplier Program. 5. Maintains FDA and USDA Facility Registrations for both corporate and branch locations. 6. Creates and maintains Product Data Sheets for Manufactured and Re-sale items. · Perform special projects as required by management. QUALIFICATIONS: · Education: Bachelors degree in a Science Related Field (Food Nutrition, Food Science, Biology, Chemistry) or equivalent preferred · Experience: Previous Food Documentation Compliance preferred COMPENSATION/BENEFITS: Competitive compensation package including profit sharing. Excellent benefits including: o Medical - We pay 90% of weekly premiums for employees o Dental o Vision o Disability insurance o Life insurance o Paid Time Off o 401(k) with Company match o Company paid holidays Gold Medal is an equal opportunity employer.

In this role you The Senior Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products. This may include ventilators, oxygenators, and other accessories. The role will provide day-to-day regulatory support for new product development and sustaining activities including but not limited to change order support, regulatory planning, and other activities as directed by management. Your role: * The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW * Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents. * Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process. * Support activities required to maintain regulatory compliance as new or revised versions of standards and guidance documents are published. * Monitor global regulatory landscapes and support implementation of regulation changes and executes quality plans to minimize business impact. Provides Regulatory assessment of product changes for launch and sustaining activities. You're the right fit if: * Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. * 5+ years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent OR 2+ years' experience with Master's Degree * Experience with Regulatory Requirements - 21 CFR 820, EU MDR, ISO 13485, Regulatory Standards, Regulatory Submission Documentation - 510k, Health Canada licenses, EU MDR Technical Documentations, Product Registrations - US, EU, Canada, Product Labeling - US, EU, Canada * Preferred Skills: Regulatory Requirements,Quality Management Systems (QMS),Troubleshooting,KPI Monitoring and Reporting,Data Analysis & Interpretation,Process Improvements * You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an office role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. * Learn more about our culture. Philips Transparency Details The pay range for this position in Murrysville, PA is $100,040 to $127,400 Annually. The pay range for this position in Cambridge, MA is $109,100 to $135,000 Annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Murrysville, PA or Cambridge, MA. #LI-PHI This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

SummaryThe Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory strategy and various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in the U.S. The Senior RA Specialist will also support related regulatory affairs activities, such as development, execution and management of procedures and systems to ensure that the product development process - including clinical studies and strategy - addresses all regulatory requirements and objectives of the business. The incumbent should have demonstrated leadership and success working in cross-functional teams and will perform essential duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) Understands and has expertise in US Pharmaceutical and OTC Monograph regulations and develops different regulatory pathways and communicates options to cross functional teams. Provides regulatory guidance for one or more program(s), including participation in external Food and Drug Administration (FDA) meetings, internal core team meetings and providing technical guidance on complex regulatory issues. Creates and manages programs with multiple workstreams and identifies key dependencies and critical path items. Develops and leverages working relationships with key personnel/representatives from FDA and oversees communications with regulators. Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes. Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims. Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to an approved (A) NDA Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses. Assess necessity for reporting changes to FDA for device modifications. Prepare robust justifications for changes that do not require notices. Address and resolve requests for additional information. Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives. Support OUS RA team members in order to maintain effective collaboration and to synchronize domestic and international submissions. Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures. Manage and maintain the drug registrations and listings (CDER Direct/eDURLS) system and complete CARES Act reporting. Support the submission of SPL via ESG/CDER Direct for all drug labeling in the US. Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities. Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents. Support the quality system and internal/external audits. Education and Experience: Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of five years of experience, with demonstrated support of regulatory submission development and approval from the FDA and other global regulatory agencies. Excellent organizational and communications skills. Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required. Experience navigating FDA databases required. Experience with EU MDR preferred. Experience with electronic submissions and ERP systems is preferred. Knowledge and Skills: Required Qualifications: Proficient in using Microsoft Word, Excel, PowerPoint, and OneNote. Strong communication (written, oral) and project management skills. Ability to plan and schedule multiple priorities in a concurrent fashion. Ability to review, collate and summarize scientific and technical data. Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. Excellent problem solving and analytical skills. Excellent written and oral communication skills with ability to effectively communicate at varying levels in the organization. Experience with authoring NDAs/ANDAs. (CTD Format) Experience authoring and managing regulatory submissions and/or registrations, with responsibility for communicating with regulatory authorities. Experience facilitating and designing communication strategies to FDA. Preferred Qualifications: Advanced degree Experience with regulatory tools and systems. (CDER Direct/eDURLS) Knowledge/Expertise of Quality Systems. Proven background managing complex and strategic regulatory projects from initiation to conclusion. Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy. Previous experience facilitating meetings with FDA, reviewing submissions, registrations and/or notifications from varying product lines or programs. Physical Demands: (if applicable) While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations. Work Environment: (if applicable) While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. This is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA RI - WarwickAdditional LocationsUSA IL - Vernon Hills, USA TX - El Paso - Northwestern Dr.Work Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $92,700.00 - $152,900.00 USD Annual

**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **_Remote employees must reside in one of the following states: MD, VA, DC, PA, WV, CA, MI, IL, KS, FL, NC, or MN._** **Brief Job Overview** The Associate Hazard Communication Regulatory Compliance Specialist is an entry level position in USP's Hazard Communication Program (HCP), responsible for assisting in the preparation of Safety Data Sheets (SDS), hazard labels, and compliance with the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The **Associate Hazard Communication Regulatory Compliance Specialist** has the following responsibilities: + [60 %] Under the supervision of senior staff, research toxicological, chemical, and physical properties of USP chemical products to determine acute and chronic human health hazards, physical hazards relating to fire and accidental release, and hazards to the environment and create safety data sheets and labels. + [40 %] Provide Handling Categories, potency evaluations, and any other requested safety information to USP staff and customers as required by law and as requested. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + Bachelor's degree in chemistry or sciences-related discipline. + Excellent written and oral communication skills, especially the ability to communicate in a fast-paced, time-sensitive team environment. + Ability to research, think critically, analyze conflicting data, and evaluate information sources. + Highly organized with excellent attention to detail and able to work independently as well as an effective team member. + Proficiency in computer applications (MS Word, Excel) and database experience. **Additional Desired Preferences** + Knowledge of toxicology, industrial hygiene, hazard and risk communication, and chemical regulation. **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Hourly Range: USD $32.97 - $41.85 per hour. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Laboratory/Production **Job Type** Full-Time

The Global Regulatory Specialist is responsible for the applied ingredients and regulatory compliance for consumer products with a focus on international documentation requirements. This role will assist with various projects, including formula and label reviews, product registration claims and support the work associated with obtaining government approval for product imports into international markets. Work Schedule: This position currently follows a hybrid work model. Employees are required to work from the office at least four days per week (Monday - Thursday), with Friday available for remote work, offering a blend of in-person collaboration and flexibility. Essential Duties & Responsibilities (Other duties may be assigned) * Support internal areas by serving as a subject matter expert in assigned markets through interpretation of regulations and providing guidance in the development of products. * Perform and ensure regulatory compliance of products, labels, advertising, and promotions as well as adherence to Isagenix policies and guidelines. * Assist with identifying and maintaining procedures for the registration and exporting of ingredients and products into assigned markets. * Review and ensure compliance and technical accuracy with formulation, label graphics, and ingredient claims. * Interact with cross-functional staff across various business units, partners, contractors, lawyers, and government entities to support effective product registration and launch in assigned markets. * Partner with R&D and other business teams to identify export processing and workflow opportunities. * Stay abreast of international regulatory developments in multiple markets and identify opportunities and/or implications to the business. * Maintain accurate and up-to-date regulatory records and databases. * Assist with resolving regulatory issues pertaining to labeling and handle any complex issues or problems with minimal assistance. * Possess comprehensive knowledge of subject matter. Minimum Qualifications (These are the requirements that all applicants MUST HAVE to be considered for this position) * Bachelor's Degree from an accredited institution or equivalent experience. * 1-3 years of experience in a consumer product regulatory affairs position. Preferred Qualifications * Bachelor's Degree in food science, chemistry, biology, or related technical field. * Bilingual Spanish and English Location : Company Overview Established in 2002, Isagenix International has created simple, proven products that optimize what your body is capable of-helping you protect your greatest asset, your health. For more than twenty years, Isagenix has made holistic science an art with transparency and integrity-creating products and systems that address nutrition, stress, fitness, energy, natural beauty, focus, and financial wellbeing. The global wellbeing company, based in Gilbert, Arizona, markets its products through a network of independent distributors in 22 key markets: the United States, Canada, Puerto Rico, Australia, New Zealand, Mexico, the United Kingdom, Ireland, the Netherlands, Belgium, Spain, Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Sweden, and Switzerland. For more information, visit Isagenix.com. Location : EEO Isagenix International, LLC is an equal opportunity employer and affords equal opportunity to all applicants for all positions without regard to race, color, religion, sex, national origin, age, disability, veteran status or any other status protected by law.

The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep & Respiratory Care products in the U.S., EU, and Rest of World products. Your role: * Author 510K submissions, pre-sub documents, EUMDR tech files, and will contribute to international regulatory submissions. * Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development. * Act as a Regulatory Subject Matter Expert (SME) on various aspects and provide strategic guidance to other RA Staff and project team. Able to manage special projects across a spectrum of product lines. * Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes. * Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. * Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory SME. * Review labeling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. * Identify areas for improvement for efficiency improvement and compliance in internal processes, work instructions, and forms. Apply technical expertise to process improvement efforts. You're the right fit if: * You've acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. * You have proven expertise in Software as a Medical Device (SaMD), IEC 82304 (safety) and IEC 81001-5-1/ISO 27001 (Information Security). * You have authored multiple 510Ks, with proven experience in EUMDR tech files, and Pre-Sub notifications submitted to the FDA. * Your skills include familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations. * You have knowledge and understanding of the software development lifecycle (SDLC). * You have a minimum of a Bachelors' Degree (Required). RAPS certification- preferred. * You have the proven ability to build strong relationships with internal and external stakeholders at all levels, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements. * You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together We believe that we are better together than a part. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office-based role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. * Learn more about our culture. Philips Transparency Details * The pay range for this position in Murrysville, PA and New Kensington, PA is $114,750 to $183,600. * The pay range for this position in Cambridge, MA is $128,520 to $205,632. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. Additional Information: * US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. * Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Murrysville, PA or New Kensington, PA or Cambridge, MA. * May travel up to 10% #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Works with International Product Managers to prioritize international product registrations and identify country specific regulatory requirements. Prepare and submit international regulatory submissions to support sales in key international markets. Interfacing with international country representatives, Notified Bodies and Representative for registrations and significant changes to products · Release regulatory ship holds once approvals are obtained. Work with International Customer Service to resolve routine order, ship holds for international shipments. Maintain databases to ensure international regulatory requirements for new registrations as well as design changes are current and up to date. Work with distributors and international partners to assess design, process, labeling changes to determine impact on existing registrations. Submit CFG applications to FDA; FSC applications to State of CA FDB and international agencies as applicable global labeling requirements in order to ensure compliant implementation post approval "}},{"field Label":"Skills","uitype":110,"value":"International regulatory requirements knowledge with a focus on China, Japan, Brazil, Mexico, Canada and MDD 93\/42\/EEC. Experience with Device registration on a global level Strong communication skills are a must"}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Apply Now","zsoid":"30142516","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"City","uitype":1,"value":"Carlsbad"},{"field Label":"State\/Province","uitype":1,"value":"CA"}],"header Name":"Regulatory Affairs Specialist","widget Id":"2**********0118069","is JobBoard":"false","user Id":"2**********0043003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"2**********1034076","FontSize":"12","location":"Carlsbad","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"fmv6cf7fa801b223c4cbf901e9c0ed9658cc2"}

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and prospective clients. This position does not have any supervisory responsibilities. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Write and implement procedures according to the current Code of Federal Regulations. + Assure that company policies are properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation. + Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports. + Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act. + Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific. + Review and maintain appropriate Site Master Files. + Manage and monitor Audit Corrective Actions. + Write audit responses pertaining to customer and/or internal observations, and track completion of actions. + Review investigations associated with DEA Controlled Products. + Submit applicable registration applications. + Prepare and present monthly Clinical metrics including Customer specific and overall departmental values. + This position may require overtime and/or weekend work. + Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance to work is an essential function of this position + Performs other duties as assigned by Manager/Supervisor. **QUALIFICATIONS:** **Required:** + Bachelor's Degree in a related field and/or 5-10 years related experience and/or training. + Basic Mathematical Skills + Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. + Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. + High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. + High Standard of Report Writing **Preferred:** + Ability to work independently and/or as part of a team. + Ability to demonstrate attention to detail. + Ability to identify and resolve problems in a timely manner. + Ability to hold oneself in a professional manner. The base salary hiring range for this position is ($69,920 - $78,660) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). **\#LI-RS1** Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and prospective clients. This position does not have any supervisory responsibilities. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Write and implement procedures according to the current Code of Federal Regulations. + Assure that company policies are properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation. + Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports. + Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act. + Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific. + Review and maintain appropriate Site Master Files. + Manage and monitor Audit Corrective Actions. + Write audit responses pertaining to customer and/or internal observations, and track completion of actions. + Review investigations associated with DEA Controlled Products. + Submit applicable registration applications. + Prepare and present monthly Clinical metrics including Customer specific and overall departmental values. + This position may require overtime and/or weekend work. + Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance to work is an essential function of this position + Performs other duties as assigned by Manager/Supervisor. **QUALIFICATIONS:** **Required:** + Bachelor's Degree in a related field and/or 5-10 years related experience and/or training. + Basic Mathematical Skills + Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. + Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. + High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. + High Standard of Report Writing **Preferred:** + Ability to work independently and/or as part of a team. + Ability to demonstrate attention to detail. + Ability to identify and resolve problems in a timely manner. + Ability to hold oneself in a professional manner. The base salary hiring range for this position is ($69,920 - $78,660) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). **\#LI-KH1** Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and prospective clients. This position does not have any supervisory responsibilities. ESSENTIAL DUTIES AND RESPONSIBILITIES: Write and implement procedures according to the current Code of Federal Regulations. Assure that company policies are properly followed and applied by all appropriate personnel. Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation. Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports. Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act. Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific. Review and maintain appropriate Site Master Files. Manage and monitor Audit Corrective Actions. Write audit responses pertaining to customer and/or internal observations, and track completion of actions. Review investigations associated with DEA Controlled Products. Submit applicable registration applications. Prepare and present monthly Clinical metrics including Customer specific and overall departmental values. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor. QUALIFICATIONS: Required: Bachelor's Degree in a related field and/or 5-10 years related experience and/or training. Basic Mathematical Skills Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. High Standard of Report Writing Preferred: Ability to work independently and/or as part of a team. Ability to demonstrate attention to detail. Ability to identify and resolve problems in a timely manner. Ability to hold oneself in a professional manner. The base salary hiring range for this position is ($69,920 - $78,660) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Job DescriptionDescription(Greenbelt, MD or Austin, TX) In this role, you will join the Regulatory Affairs Department, which provides regulatory, legislative, policy, and compliance counsel to JSI departments and JSI clients. Our department has nearly doubled this past year, adding more diverse expertise in federal and state communications policy and compliance - as our clients deploy more next-generation networks and connect more customers. We are looking for leaders to drive us into the future and individuals who are prepared to do whatever it takes to create a truly exceptional client experience every day. Key ResponsibilitiesThis role supports several different functions: Regulatory Reporting Perform daily management of JSI's web-based regulatory tracking tool to help clients mitigate risk and stay on top of their regulatory compliance requirements. This includes managing the internal tracking team and training new team members, interfacing with any third-party vendors, and ensuring client satisfaction. Ensure all projects are delivered on time within the stipulated scope and budget. Ensure resource availability and allocation. Coordinate and manage relationships with internal staff and clients. Perform product demos to potential clients and train staff on providing demos. Send proposals to potential clients and onboard new clients. Measure project performance using appropriate project management tools. Perform risk management analysis to reduce project risks. Report and escalate to upper management as appropriate. Create and maintain comprehensive project documentation. Perform policy and compliance research using internal tools and publicly available data, especially on state telecommunications regulatory matters. Other duties as assigned. Client and Business Development / Operational Excellence Prepare client communications, interest forms, templates, and tracking sheets. Manage proposal tracking system. Proofread and format documents and presentations for quality control. Monitor the Regulatory Support email account. Develop and maintain visual dashboards, Regulatory trackers, templates, and client pipelines. Update SharePoint Regulatory site Partner with the Vice President, Strategy & Operations Lead, Product Manager, and other leadership to drive operational excellence for the department and the company. Qualifications A bachelor's degree in communications or a related field. Any relevant project management-related experience Self-starter with a great attitude. Strong attention to detail and analytical skills Enjoys interacting with internal and external clients. Proficiency in software programs such as Microsoft Office (Outlook, Teams, Excel, Word, and PowerPoint), SmartSheets, and Adobe Acrobat Strong research skills Excellent organizational skills and the ability to manage and prioritize assignments in a fast-paced environment. Excellent written and oral communications skills. Ability to work well with individuals across diverse teams and cultures. BenefitsAt JSI, you will have a career that is rewarding and challenging on every level of the organization. JSI is committed to providing our employees with: Professional growth and development opportunities A diverse, dynamic, and stimulating work environment Educational opportunities A competitive salary and benefits package

SummaryThe Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. The RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Essential / Key Job Responsibilities (including supervisory and/or fiscal): Understands fundamental global regulatory requirements and different regulatory pathways. Understands scientific and health principles related to healthcare product development and regulations. Participates in core teams as regulatory lead, and provides guidance on regulatory requirements to product development teams, with some support from management. Organizes materials from preclinical and clinical studies for review and assists in the review process. Assists and/or has ownership in preparation of dossiers and submission packages for regulatory agencies. Supports development of regulatory strategies for marketing authorization for domestic and/or global markets. Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed. Assists in the preparation and sending of post-market reports and submissions. Participates in training of colleagues, as needed, for areas of expertise. Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends. Independently reviews advertising and promotional material for respective product line(s) and/or region(s) as needed. Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s). Assists in the preparation and sending of system effectiveness reports and summaries related to regulatory systems and tools, as applicable. May participate in regulatory body audits, as related to respective product line(s) and/or region(s). Required Qualifications: Bachelor's degree or Advanced degree in technical area such as biology, chemistry, engineering or medical-related field AND a minimum of one year of experience in a Regulatory role within the Medical Device industry Required. Will consider 5-7 years explicit Regulatory experience within the Medical Device industry in Lieu of education. Ability to plan and schedule multiple priorities in a concurrent fashion. Ability to review, collate, and summarize scientific and technical data. Ability to learn new technical concepts and skills. Good problem solving and analytical skills. Good written and oral communication skills. Preferred Qualifications: Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy. Ability to complete work with minimal supervision and ability to work independently. Previous experience in regulatory body audit support. Experience with regulatory tools and systems. Excellent writing and strong organizational skills. Performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations. Work Environment: While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. This is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork Shift

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and prospective clients. This position does not have any supervisory responsibilities. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Write and implement procedures according to the current Code of Federal Regulations. + Assure that company policies are properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation. + Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports. + Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act. + Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific. + Review and maintain appropriate Site Master Files. + Manage and monitor Audit Corrective Actions. + Write audit responses pertaining to customer and/or internal observations, and track completion of actions. + Review investigations associated with DEA Controlled Products. + Submit applicable registration applications. + Prepare and present monthly Clinical metrics including Customer specific and overall departmental values. + This position may require overtime and/or weekend work. + Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance to work is an essential function of this position + Performs other duties as assigned by Manager/Supervisor. **QUALIFICATIONS:** **Required:** + Bachelor's Degree in a related field and/or 5-10 years related experience and/or training. + Basic Mathematical Skills + Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. + Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. + High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. + High Standard of Report Writing **Preferred:** + Ability to work independently and/or as part of a team. + Ability to demonstrate attention to detail. + Ability to identify and resolve problems in a timely manner. + Ability to hold oneself in a professional manner. The base salary hiring range for this position is ($69,920 - $78,660) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). **\#LI-KH1** Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following and other duties as assigned. Provides the required technical documentation to support regulatory and registration requests for the NOW Sales Teams. This responsibility includes but is not limited to COAs, product specifications, vendor quality documents, allergen statements, non-GMO statements, product labels, Organic, Kosher and Halal certificates. Procures technical information from QA/QC and other company databases for the NOW sales teams for regulatory and registration requests. For documentation and registration work, reviews, proofs and confirms accuracy and correctness of documentation work based on various company documents, supplier information and other regulatory sites while ensuring conformance to GMP and other regulatory requirements. Alerts team manager, quality and sales teams of any discrepancies found. Develops a tracking system and monitors accordingly to ensure delivery of all required documentation at the expected deadline. Maintains regulatory and registration files of all work and documents provided to the sales Complies with safety and GMP SAFETY RESPONSIBILITY STATEMENT Supports a culture of safe operations; follows all safety rules and procedures. Actively participates in any safety programs by engaging in training activities to learn what constitutes a safe work environment. Fulfills responsibilities as outlined in the company safety management plan. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE Associate's degree from a two year post high school college or bachelor's degree (BA or BS) from four- year college or university with a related degree in biology, chemistry, nutrition and/or quality/regulatory compliance preferred. LANGUAGE SKILLS Ability to read, analyze, and interpret science-based documents, general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports and business correspondence. Ability to effectively present information/documentation and respond to questions from manager, colleagues and customers. OTHER SKILLS AND ABILITIES Excellent interpersonal, organizational skills and attention to detail required. Good computer skills required, including proficiency with Word and Excel. Oracle and LIMS experience and other quality technical databases a plus. REASONING ABILITY Problem solving skills required. PHYSICAL DEMANDS 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 accommodations may be made to enable individuals with disabilities to perform the essential functions. WORK ENVIRONMENT Desk and office environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 2025 BENEFITS AT A GLANCE

Our Regulatory & Clinical Affairs Specialist plays a vital role within our organization. Once you complete our training, your responsibilities will include the creation of and updates to Quva labels, Quva Bill of Materials (BOMs) at a corporate level (for all sites), maintenance of records with respect to product formulation and label information, and third-party submissions to external databases. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Regulatory & Clinical Affairs Specialist Does Each Day: Organize, create, and update labels including finished goods and intermediate bulks Organize, create, and update product formulations and Bill of Materials Complete product formulations and labels in Master Control and Infor Update the LPL-picklist Prepare data and maintain records to ensure alignment with related systems and information Routinely evaluate FDA NDCs listing from Orange Book against approved products Prepare FDA Risk Evaluation and Mitigation Strategies Monitor for updates to FDA labeling requirements, 503B labeling standards and other relevant organization updates, such as ISMP, USP 7 and ASTM Manage submissions to 3rd party databases (First Data Bank, Cerner, Medi-Span, Merative) Support investigations for Pharmacy Services-related deviations and CAPAs, and initiate Pharmacy Services labels and formulations-related Change Requests Screen 503B facilities for FDA 483s on labeling issues Resolve discrepancies related to labels and or other tasks assigned. Delegate risk management issues with team Provide backup for the Pharmacy Services Labels and Formulations team for planned and unplanned tasks as needed Our Most Successful Regulatory & Clinical Affairs Specialist: Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment) Is a self-starter and independent learner Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform Minimum Requirements for this Role: Bachelor's degree in science 2+ years in an FDA cGMP environment Desire Quality or Pharmacy experience Efficiency with MS Office suite, Excel, PowerPoint 18+ years of age Able to successfully complete a drug and background check Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas Any of the Following Will Give You an Edge: College Major in Pharmacy or Chemistry Pharmacy certification/license Benefits of Working at Quva: Set, full-time, consistent work schedule Comprehensive health and wellness benefits including medical, dental and vision 401k retirement program with company match 17 paid days off plus 8 paid holidays per year National, industry-leading high growth company with future career advancement opportunities About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.” California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

Job DescriptionDescription(Greenbelt, MD or Austin, TX) In this role, you will join the Regulatory Affairs Department, which provides regulatory, legislative, policy, and compliance counsel to JSI departments and JSI clients. Our department has nearly doubled this past year, adding more diverse expertise in federal and state communications policy and compliance - as our clients deploy more next-generation networks and connect more customers. We are looking for leaders to drive us into the future and individuals who are prepared to do whatever it takes to create a truly exceptional client experience every day. Key ResponsibilitiesThis role supports several different functions: Regulatory Reporting Perform daily management of JSI's web-based regulatory tracking tool to help clients mitigate risk and stay on top of their regulatory compliance requirements. This includes managing the internal tracking team and training new team members, interfacing with any third-party vendors, and ensuring client satisfaction. Ensure all projects are delivered on time within the stipulated scope and budget. Ensure resource availability and allocation. Coordinate and manage relationships with internal staff and clients. Perform product demos to potential clients and train staff on providing demos. Send proposals to potential clients and onboard new clients. Measure project performance using appropriate project management tools. Perform risk management analysis to reduce project risks. Report and escalate to upper management as appropriate. Create and maintain comprehensive project documentation. Perform policy and compliance research using internal tools and publicly available data, especially on state telecommunications regulatory matters. Other duties as assigned. Client and Business Development / Operational Excellence Prepare client communications, interest forms, templates, and tracking sheets. Manage proposal tracking system. Proofread and format documents and presentations for quality control. Monitor the Regulatory Support email account. Develop and maintain visual dashboards, Regulatory trackers, templates, and client pipelines. Update SharePoint Regulatory site Partner with the Vice President, Strategy & Operations Lead, Product Manager, and other leadership to drive operational excellence for the department and the company. Qualifications A bachelor's degree in communications or a related field. Any relevant project management-related experience Self-starter with a great attitude. Strong attention to detail and analytical skills Enjoys interacting with internal and external clients. Proficiency in software programs such as Microsoft Office (Outlook, Teams, Excel, Word, and PowerPoint), SmartSheets, and Adobe Acrobat Strong research skills Excellent organizational skills and the ability to manage and prioritize assignments in a fast-paced environment. Excellent written and oral communications skills. Ability to work well with individuals across diverse teams and cultures. BenefitsAt JSI, you will have a career that is rewarding and challenging on every level of the organization. JSI is committed to providing our employees with: Professional growth and development opportunities A diverse, dynamic, and stimulating work environment Educational opportunities A competitive salary and benefits package

States considered: Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow. Benefits Include: $500 sign on bonus! Great Health Benefits from day 1! 4 weeks accrued paid vacation and 13 paid holidays 401(k) match with company profit sharing Tuition reimbursement Position Summary Manage US domestic and international regulatory compliance activities for Lincoln Operations with emphasis on USDA, DEA and FDA activities, registration change controls (including defending technical data to country authorities), serial variations, market actions/recalls, artwork review and approval and annual compliance reviews (Outlines of Production & Administrative Audit). This position serves as the principle back-up to the Primary Liaison for the USDA Center of Veterinary Biologics Inspection & Compliance. Position Responsibilities Manage the completion of the following responsibilities: Manage all site DEA registrations. Ensure all regulatory requirements are met. Serve as a key Zoetis Establishment 190 representative to USDA & international regulatory colleagues and agencies regarding compliance and registration support activities. Perform, review, and approve investigations into biological product complaints to ensure products released in the market are safe, pure, potent, and efficacious. Perform periodic trending of complaints and identify opportunities for product improvements to eliminate product defects. Ensure investigations meet the requirements and expectations of the relevant regulatory authority. Present periodic trends to LSQC. Manage pharmaceutical and biological registration change control, including the annual outline of production review, QQFs and RCR/SARs. Support/assist with miscellaneous regulatory support functions such as the annual administrative inspection review, market actions/recalls, periodic blueprint & legend updates and artwork review and approval. Assess and determine need for regulatory notifications. Defend registration process deviations (variations) to USDA and other appropriate regulatory agencies. Monitor regulatory communications and ensure that any commitments to the agencies are endorsed by leadership and communicated. Ensure commitments are met and/or communicate progress to the regulatory authority. Maintain a thorough knowledge of USDA, FDA and DEA regulatory requirements associated with the testing and manufacturing of veterinary products. Advise management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements. Participate in industry and trade association committees to align Zoetis Quality Standards, government regulations, and the quality needs of Animal Health customers. Organizational Relationships Interact with Manufacturing, QA, QC, VMRD, Pharmacovigilance and VMIPS. Interface and interact with other USDA Establishment License 190 Facilities. Education and Experience D.V.M. and/or Ph.D. with 5 years, M.S. with 7 years, B.S. with 10 years or equivalent in biological or pharmaceutical sciences, or related discipline. Technical Skills and Competencies Required Minimum Qualifications: In-depth knowledge of USDA, DEA, and FDA regulatory requirements for an international veterinary biological/pharmaceutical manufacturing site. Excellent written, oral, and interpersonal skills and ability to work in a team environment Demonstrated ability to perform and reach targeted conclusions. Ability to establish appropriate timelines to meet project milestones and timelines. Process and detail oriented with the ability to review and/or prepare detailed structured documents. Ability to develop solutions to routine and complex problems. Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work. Ability to communicate effectively with Team Members to facilitate completion of required investigation activities to meet all deadlines. Preferred Qualifications: Demonstrated experience in the ability to influence and negotiate with external regulators. Demonstrated experience performing and/or approving investigations into deviations and/or product complaints. Demonstrated knowledge of the deviation, change control, laboratory information management and manufacturing systems. Physical Position Requirements This position requires sitting, standing, and walking with occasional overtime/weekend work. Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Full-time Description Join Safeguard Medical - Where Purpose Meets Innovation At Safeguard Medical, we're not just shaping the future of emergency medicine-we're saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts. Our mission is clear: To equip and enable responders at every skill level to preserve life in any environment. Our vision is bold: To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most. Our purpose is powerful: To bring together life-saving products and the knowledge of emergency medical skills that preserve life. From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we're building a global movement-one that gives first responders the tools they need to make a difference in the toughest conditions. If you're driven by impact, inspired by innovation, and ready to grow in a company that's changing lives-this is your moment. About the Role We're on the lookout for a passionate Regulatory Specialist to join our team onsite full time in Huntersville, NC. This isn't just a job-it's a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe. What You'll Be Doing in This Role As a Regulatory Specialist, you'll be right at the heart of our mission to preserve life. The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide. Your key objectives: • Reviewing labeling, training, and promotional material • Supporting product and shipping release. • Maintaining FDA's GUDID database • Updating and reviewing technical file updates • Reviewing External Standards • Supporting business with government queries and registration documentation requirements. • Reviewing Change Orders and assessing regulatory impact of product changes on US and/or International regulatory strategy and submissions • Supporting post market regulatory compliance activities for US/International product approvals • Assisting with the development and maintenance of regulatory affairs department procedures • Complying with applicable FDA and international regulatory laws/standards • Ensuring relevant ISO and FDA Export requirements are met, as required • Performing coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. • Ensuring all materials comply to support submissions, license renewal and annual registrations. • Keeping abreast of regulatory procedures and changes. • Providing support to Customer Service Requirements You won't just be filling a role-you'll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most. Is This You? We're looking for someone who's ready to jump in and make a difference. Could that be you? You thrive in a team and bring a positive, can-do attitude to everything you do You're passionate about helping others and want to be part of something that truly matters in emergency medicine Ability to focus and achieve scheduled milestones, including contingency planning. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed. Exercise outstanding judgment in all areas of responsibility. Ability to travel up to 15% You possess the following: · Bachelor's Degree required · At least 2 years of Regulatory Affairs experience in Medical device · Working knowledge of relevant domestic and global regulations and guidance · History of successful interactions with global regulatory authorities · Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems. · A combination of education and experience may be considered · Knowledge of FDA, MDD, EU MDR · Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility). · RAC certification is a plus If you're nodding along, we'd love to hear from you. Why Safeguard Medical? This is more than a career move-it's a chance to join a fast-paced, purpose-led company where your work truly matters. You'll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow. Be part of a mission-driven organization with global impact Work with life-saving technologies and innovative solutions Join a collaborative, supportive, and inclusive team Build your career in a company that invests in people and progress Our Culture: Powered by Our DNA At Safeguard Medical, our culture is built on values that drive us every day: Ownership - We take charge, own our impact, and push for success. Initiative - We act boldly and do what's right, fast. Curiosity - We ask “why?”, explore better ways, and embrace diverse views. Candor - We speak openly and respectfully to align and move forward. Humility - We lead selflessly, knowing success is shared. We believe in learning from each other, valuing every voice, and creating a space where everyone belongs-regardless of background, identity, or ability. What You'll Get in Return We believe great people deserve great rewards. Here's what we offer to support your wellbeing, growth, and success Comprehensive insurance packages - peace of mind for you and your loved ones with medical, dental, vision and life insurance Competitive pay & performance bonus - because your impact deserves recognition Retirement support - employer contribution to help secure your future Generous time off allowance - time to recharge and enjoy life outside of work Employee Assistance Program (EAP) - confidential support when you need it most Tuition reimbursement &referral programs - invest in your growth and help us grow too Ready to Make a Difference? Ready to join our team? We'd love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities. Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.

Job DescriptionDescription: Join Safeguard Medical - Where Purpose Meets Innovation At Safeguard Medical, we're not just shaping the future of emergency medicine-we're saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts. Our mission is clear: To equip and enable responders at every skill level to preserve life in any environment. Our vision is bold: To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most. Our purpose is powerful: To bring together life-saving products and the knowledge of emergency medical skills that preserve life. From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we're building a global movement-one that gives first responders the tools they need to make a difference in the toughest conditions. If you're driven by impact, inspired by innovation, and ready to grow in a company that's changing lives-this is your moment. About the Role We're on the lookout for a passionate Regulatory Specialist to join our team onsite full time in Huntersville, NC. This isn't just a job-it's a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe. What You'll Be Doing in This Role As a Regulatory Specialist, you'll be right at the heart of our mission to preserve life. The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide. Your key objectives: • Reviewing labeling, training, and promotional material • Supporting product and shipping release. • Maintaining FDA's GUDID database • Updating and reviewing technical file updates • Reviewing External Standards • Supporting business with government queries and registration documentation requirements. • Reviewing Change Orders and assessing regulatory impact of product changes on US and/or International regulatory strategy and submissions • Supporting post market regulatory compliance activities for US/International product approvals • Assisting with the development and maintenance of regulatory affairs department procedures • Complying with applicable FDA and international regulatory laws/standards • Ensuring relevant ISO and FDA Export requirements are met, as required • Performing coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. • Ensuring all materials comply to support submissions, license renewal and annual registrations. • Keeping abreast of regulatory procedures and changes. • Providing support to Customer Service Requirements: You won't just be filling a role-you'll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most. Is This You? We're looking for someone who's ready to jump in and make a difference. Could that be you? You thrive in a team and bring a positive, can-do attitude to everything you do You're passionate about helping others and want to be part of something that truly matters in emergency medicine Ability to focus and achieve scheduled milestones, including contingency planning. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed. Exercise outstanding judgment in all areas of responsibility. Ability to travel up to 15% You possess the following: · Bachelor's Degree required · At least 2 years of Regulatory Affairs experience in Medical device · Working knowledge of relevant domestic and global regulations and guidance · History of successful interactions with global regulatory authorities · Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems. · A combination of education and experience may be considered · Knowledge of FDA, MDD, EU MDR · Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility). · RAC certification is a plus If you're nodding along, we'd love to hear from you. Why Safeguard Medical? This is more than a career move-it's a chance to join a fast-paced, purpose-led company where your work truly matters. You'll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow. Be part of a mission-driven organization with global impact Work with life-saving technologies and innovative solutions Join a collaborative, supportive, and inclusive team Build your career in a company that invests in people and progress Our Culture: Powered by Our DNA At Safeguard Medical, our culture is built on values that drive us every day: Ownership - We take charge, own our impact, and push for success. Initiative - We act boldly and do what's right, fast. Curiosity - We ask “why?”, explore better ways, and embrace diverse views. Candor - We speak openly and respectfully to align and move forward. Humility - We lead selflessly, knowing success is shared. We believe in learning from each other, valuing every voice, and creating a space where everyone belongs-regardless of background, identity, or ability. What You'll Get in Return We believe great people deserve great rewards. Here's what we offer to support your wellbeing, growth, and success Comprehensive insurance packages - peace of mind for you and your loved ones with medical, dental, vision and life insurance Competitive pay & performance bonus - because your impact deserves recognition Retirement support - employer contribution to help secure your future Generous time off allowance - time to recharge and enjoy life outside of work Employee Assistance Program (EAP) - confidential support when you need it most Tuition reimbursement &referral programs - invest in your growth and help us grow too Ready to Make a Difference? Ready to join our team? We'd love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities. Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.