Regulatory Affairs Specialist - Et

Medtronic

Base: $73,600.00 - $110,400.00 usd; bonus/equity: ...
Onsite
Regulatory submissions preparation
Fda and international regulatory compliance
Medical device regulatory strategy
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 role offers primary regulatory responsibility for multiple Class II and/or Class III medical devices, working within a collaborative team environment that fosters professional development.
  • Medtronic offers a competitive salary, flexible benefits package, and a wide range of resources designed to support employees at every career and life stage.

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: $73,600.00 - $110,400.00 USD; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, dental, vision insurance, 401(k) with employer match, paid time off, employee stock purchase plan

Skills & Requirements

Must-have

  • Regulatory submissions preparation
  • FDA and international regulatory compliance
  • Medical device regulatory strategy
  • Post-market regulatory support
  • Cross-functional team collaboration
  • Regulatory documentation management

Nice-to-have

  • Strong analytical thinking skills
  • Excellent communication skills
  • Presentation skills for small groups
  • Ability to manage multiple priorities
  • Detail-oriented and flexible
  • Interpersonal skills

Key Requirements

  • Bachelor’s Degree in Engineering or Life Sciences
  • 2+ years related regulatory experience or Masters with 0 years
  • Understanding of FDA and global regulatory standards
  • US work authorization required at hire
  • Experience with ISO 13485 and ISO 14971
  • Ability to review technical and design specifications

Work Rights

Must have unrestricted US work authorization at time of hire

Tailored Resume

Cover Letter