Sr. Regulatory Affairs Specialist - Pelvic Health

MEDTRONIC

Minnesota, United States
Base: $92,000.00 - $138,000.00; bonus/equity: not ...
Onsite
Experience with class iii medical devices
Regulatory submissions for fda and eu
Knowledge of iso 14971 and iso 13485
Medtronic is committed to championing healthcare access and equity for all

Job Summary

  • Medtronic is committed to championing healthcare access and equity for all.
  • The Senior Regulatory Affairs Specialist will lead strategies for worldwide product registration.
  • This role offers a competitive salary and a flexible benefits package.

Matching Summary

Medtronic is committed to championing healthcare access and equity for all.

Salary

Base: $92,000.00 - $138,000.00; Bonus/Equity: Not specified; Benefits: Health, Dental and vision insurance, 401(k) plan

Skills & Requirements

Must-have

  • Experience with Class III medical devices
  • Regulatory submissions for FDA and EU
  • Knowledge of ISO 14971 and ISO 13485

Nice-to-have

  • Strong negotiation and communication skills
  • Ability to work independently
  • Experience in a regulated biotechnology environment

Key Requirements

  • Bachelor's degree in a scientific discipline
  • 4 years of relevant experience
  • Experience in regulatory, engineering, clinical, or quality roles

Work Rights

Must have unrestricted U.S. work authorization

Tailored Resume

Cover Letter