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.A Day in the Life                  This position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical & Regulatory Solutions (MCRS) 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. A role within MCRS offers a unique opportunity to be part of a global, high-impact team, collaborating across functions, gaining visibility into enterprise-wide structures, and contributing to initiatives that drive meaningful impact across Medtronic.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.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Open to candidates based at Medtronic locations across the U.S.Responsibilities may include the following and other duties may be assigned:Lead and develop a high-performing team focused on product release and regulatory executionLead end-to-end regulatory product release strategy and execution, ensuring compliance with global regulatory requirementsDrive process standardization, simplification, and automation across product release workflowsLead data quality initiatives to support compliant global submissions and product distributionOversee regulatory distribution control processes (e.g., GTS/SAP) to enable timely and accurate product releaseLead continuous improvement initiatives focused on cycle time, quality, and scalability of release processesEstablish and monitor KPIs, dashboards, and reporting to track performance and complianceBuild organizational capability in regulatory systems, data, and operational executionMinimum RequirementsBachelor’s degree7+ years of experience supporting or leading product release, distribution control, or regulatory operations processes (or 5+ years with advanced degree)5+ years of managerial experienceStrong knowledge of global regulatory requirements impacting product distribution (FDA, EU MDR, international markets)Nice to Have Organizational skills and highly detail orientedIntermediate knowledge of spreadsheet and database applications (Microsoft Office, and SharePoint)Analytical and problem-solving skillsExcellent communication skillsEffective project management skillsExperience with GTS/SAP, UDI (GUDID/EUDAMED), and/or RIM systemsExperience in regulatory data management, governance, or digital transformationExperience driving process harmonization across global organizationsProven ability to work in complex, matrixed organizations and influence stakeholdersFor Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe 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. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. 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. The offered rate complies with federal and local regulations and may vary based on factors