Sr Regulatory Affairs Manager

Medtronic Diabetes

Lafayette, CO, USA
Base: $154,400.00 - $231,600.00; bonus/equity: eli...
Onsite (4 days per week)
7 years relevant experience
5+ years managerial experience
Us/eu regulatory compliance
Medtronic Diabetes is seeking a Sr. Regulatory Affairs Manager to lead worldwide product approval submissions and ensure compliance for Acute Care and Monitoring products. The ideal candidate will have extensive experience in regulatory affairs, particularly in medical devices, and will work closely with cross-functional teams to drive innovation and business goals

Job Summary

  • The role involves establishing global regulatory strategies for Acute Care and Monitoring products to support business objectives.
  • Candidates must lead a high-performance team, providing career coaching and managing performance evaluations from entry-level to Principal.
  • Medtronic offers a competitive salary range of $154,400.00 to $231,600.00 along with comprehensive benefits including health insurance and 401(k) matching.

Matching Summary

Match Score: 85

Medtronic Diabetes is seeking a Sr. Regulatory Affairs Manager to lead worldwide product approval submissions and ensure compliance for Acute Care and Monitoring products. The ideal candidate will have extensive experience in regulatory affairs, particularly in medical devices, and will work closely with cross-functional teams to drive innovation and business goals.

Salary

Base: $154,400.00 - $231,600.00; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), PTO, Tuition assistance

Skills & Requirements

Must-have

  • 7 years relevant experience
  • 5+ years managerial experience
  • US/EU regulatory compliance
  • FDA and EU MDR knowledge
  • Medical device submissions
  • Team leadership and coaching

Nice-to-have

  • Engineering degree background
  • Advanced degree preferred
  • High-performance culture development
  • Talent recognition and development
  • Cross-functional collaboration skills

Key Requirements

  • Bachelor's Degree with 7+ years experience or Advanced Degree with 5+ years
  • Minimum 5+ years of managerial experience
  • Unrestricted US work authorization required
  • Proven track record leading high performing teams

Work Rights

Must have unrestricted US work authorization at time of hire

Tailored Resume

Cover Letter