MED Medtronic Inc · Minneapolis, MN

Senior Regulatory Affairs Manager at MED Medtronic Inc — Minneapolis, MN

Full-timeMinneapolis, MNPosted 2026-07-15Apply on Workday
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Full job description

We anticipate the application window for this opening will close on - 4 Aug 2026

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.

Open to candidates based at Medtronic locations across the U.S.

  • 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

U.S. Work Authorization & Sponsorship

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Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$154,400.00 - $231,600.00