Senior Regulatory Affairs Manager

We anticipate the application window for this opening will close on - 10 Jul 2026. At Medtronic you can begin a life‑long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical & Regulatory Solutions organization and leads the global Product Release team. The role is responsible for providing strategic direction and people leadership, coaching and developing managers and teams to deliver timely, accurate, and compliant product releases in support of global market access. Open to candidates based at Medtronic locations across the U.S. Responsibilities Lead and develop a high‑performing team focused on product release and regulatory execution Lead end‑to‑end regulatory product release strategy and execution, ensuring compliance with global regulatory requirements Drive process standardization, simplification, and automation across product release workflows Lead data quality initiatives to support compliant global submissions and product distribution Oversee regulatory distribution control processes (e.g., GTS/SAP) to enable timely and accurate product release Lead continuous improvement initiatives focused on cycle time, quality, and scalability of release processes Establish and monitor KPIs, dashboards, and reporting to track performance and compliance Build organizational capability in regulatory systems, data, and operational execution Minimum Requirements Bachelor’s degree 7+ years of experience supporting or leading product release, distribution control, or regulatory operations processes (or 5+ years with advanced degree) 5+ years of managerial experience Strong knowledge of global regulatory requirements impacting product distribution (FDA, EU MDR, international markets) Nice to Have Organizational skills and highly detail oriented Intermediate knowledge of spreadsheet and database applications (Microsoft Office, and SharePoint) Analytical and problem‑solving skills Excellent communication skills Effective project management skills Experience with GTS/SAP, UDI (GUDID/EUDAMED), and/or RIM systems Experience in regulatory data management, governance, or digital transformation Experience driving process harmonization across global organizations Proven ability to work in complex, matrixed organizations and influence stakeholders Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co‑workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise‑wide workforce planning approach, U.S. work authorization sponsorship (H‑1B, TN, J, etc.) is offered exclusively for Principal‑level roles and above, where specialized expertise aligns with long‑term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Benefits & Compensation Salary ranges for U.S (excl. PR) locations (USD):$154,400.00 - $231,600.00. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. 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 Simple Steps (global well‑being program) 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 Equal Employment Opportunity 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. #J-18808-Ljbffr