Principal Regulatory Affairs Specialist

Medtronic

Jacksonville, Florida, US
Base: $118,400.00 - $177,600.00; bonus/equity: eli...
Onsite
Support product development
Maintain product compliance
Interpret regulatory requirements
At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all

Job Summary

  • At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
  • This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products.
  • Medtronic offers a competitive Salary and flexible Benefits Package including Health, Dental and vision insurance, 401(k) plan plus employer contribution and match, and Paid time off.

Matching Summary

At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.

Salary

Base: $118,400.00 - $177,600.00; Bonus/Equity: Eligible for short-term incentive (MIP); Benefits: Health, Dental, vision, HSA, FSA, Life insurance, LTD, Dependent daycare, Tuition assistance, 401(k) match, PTO, Holidays, ESPP, EAP, Non-qualified Retirement Plan Supplement, Capital Accumulation Plan

Skills & Requirements

Must-have

  • support product development
  • maintain product compliance
  • interpret regulatory requirements
  • lead submission activities
  • review change orders
  • review labeling and promotional material

Nice-to-have

  • high tolerance to ambiguity
  • mentor regulatory staff
  • champion healthcare access and equity
  • drive performance and foster belonging

Key Requirements

  • Bachelor's Degree with 7+ years experience
  • Master's Degree with 5+ years experience
  • 7+ years medical device regulatory affairs experience
  • 5+ years medical device regulatory affairs experience
  • Experience with 510(k) or PMA submissions
  • Experience with EU Technical Files

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter