Sr. Regulatory Affairs Specialist - Pelvic Health

Medtronic UK

Minneapolis, United States
Base: $92,000.00 - $138,000.00; bonus/equity: mip ...
Onsite
Medical device experience
Class iii medical devices (pma)
Fda, eu mdr submissions
You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world

Job Summary

  • You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
  • The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to market.
  • Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values.

Matching Summary

You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Salary

Base: $92,000.00 - $138,000.00; Bonus/Equity: MIP eligible; Benefits: Health, Dental, Vision, 401k, PTO, etc.

Skills & Requirements

Must-have

  • Medical Device Experience
  • Class III medical devices (PMA)
  • FDA, EU MDR submissions
  • ISO 14971, ISO 13485 knowledge
  • Negotiation, written, oral communication
  • Time management, multitasking, prioritization

Nice-to-have

  • Work in regulated biotechnology environment
  • Engineering or Cybersecurity / Software / AI experience
  • History of successful device submissions
  • Lead with purpose, break down barriers

Key Requirements

  • Bachelor’s degree in scientific discipline or equivalent with 4 years experience
  • Advanced degree with 2 years experience
  • 5-8 years industry experience
  • 2-3 years regulatory, engineering, clinical, or quality roles
  • Unrestricted U.S. work authorization

Work Rights

Unrestricted US work authorization required for roles below Principal level

Tailored Resume

Cover Letter