Sr. Regulatory Affairs Specialist

Sr. Regulatory Affairs SpecialistPosition 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.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 yearThe 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.