Sr. Regulatory Affairs Specialist - Pelvic Health

Medtronic

Rice Creek East, Minnesota, United States
Base: $92,000.00 - $138,000.00; bonus/equity: elig...
Onsite
Direct experience with class iii medical devices
Fda, eu mdr, and global regulatory submission expertise
Knowledge of iso 14971 and iso 13485 standards
This role involves developing strategies for worldwide product registration and preparing submissions for FDA, European, and Canadian agencies

Job Summary

  • This role involves developing strategies for worldwide product registration and preparing submissions for FDA, European, and Canadian agencies.
  • The position requires direct interaction with regulatory agencies at the reviewer level and collaboration with engineers to resolve potential regulatory issues.
  • Medtronic offers a competitive salary range of $92,000.00 - $138,000.00 along with comprehensive benefits including health insurance, 401(k) matching, and incentive plans.

Matching Summary

This role involves developing strategies for worldwide product registration and preparing submissions for FDA, European, and Canadian agencies.

Salary

Base: $92,000.00 - $138,000.00; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • Direct experience with Class III medical devices
  • FDA, EU MDR, and global regulatory submission expertise
  • Knowledge of ISO 14971 and ISO 13485 standards
  • Experience with PMA filings and license maintenance
  • Ability to interact directly with FDA reviewers

Nice-to-have

  • Engineering or cybersecurity software AI experience
  • Experience in regulated biotechnology environments
  • History of successful device submissions
  • Advanced degree in scientific discipline
  • Strong negotiation and communication skills

Key Requirements

  • Bachelor's degree in scientific discipline with 4 years experience
  • Unrestricted US work authorization required
  • Minimum 4 years relevant industry experience
  • No sponsorship available for this role level

Work Rights

Must have unrestricted US work authorization

Tailored Resume

Cover Letter