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We anticipate the application window for this opening will close on - 30 Dec 2025 Position Description: Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for developing strategies for worldwide product registration with global regulatory agencies to introduce Wound Management devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations. Provide Regulatory Affairs support for maintenance of Core Suture Portfolio including regulatory activities throughout the entire product lifecycle, including pre-clinical, clinical, regulatory approval, and postapproval phases. Navigate key Regulations and Guidance Documents including MDR Regulation (EU) 2017/745, UK MDR, FDA CFR 21, and guidances such as NBOG, MDCG, and FDA Deciding When to Submit a 510(k) in order to assess the Regulatory impact of product modifications, new product development projects, Issue Impact Assessments, and Supplier Change Requests, for the Core Suture portfolio. Analyze and monitor global and local regulations and standards applicable to medical products, ensuring compliance with regulatory requirements from agencies while identifying risks and opportunities. Support Manufacturing Site Inspections and Audits, ensuring compliance with applicable requirements and supporting regulatory agency interactions. Support Globalization of Core Suture Portfolio including development and execution of regulatory strategies to support product registration and market access in US and international markets including Egypt, LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971. Position works a hybrid model, requiring the employee to be onsite in North Haven, CT 3-4 days per week. #LI-DNI Basic Qualifications: Requires a Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Biomedical Sciences, or closely related field and four (4) years of experience as a Regulatory Affairs Specialist or related occupation in regulatory affairs. Must possess at least four years’ experience with each of the following: Regulatory full product lifecycle for Class III medical devices, including pre-clinical, clinical, approval, and post-approval with MDR implementation; MDR Regulation (EU) 2017/745, and FDA CFR 21, and guidance including NBOG, MDCG, and FDA Deciding When to Submit a 510(k) for a Change to review projects, change controls, IIAs, and SCRs for Class III medical devices, providing regulatory assessments; Track changes for relevant standards and regulations, assess regulatory impact and provide gap assessments for regulatory requirements for product development and commercialization; Supporting manufacturing site inspections and audits, ensuring compliance with applicable requirements and supporting regulatory agency interactions; Developing and executing regulatory strategies to support product registration and market access in US and international markets including LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971. Salary: $112,000 to $138,000 per year #LI-DNI The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com