Senior Regulatory Affairs Manager
About The Position
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.
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)
- For 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.
- The employee is also required to interact with a computer, and communicate with peers and co-workers.
- 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.
Nice To Haves
- 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
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
Benefits
- 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)
- 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)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
