Regulatory Affairs Specialist -neuro

Medtronic Diabetes

Rice Creek East, MN, USA
Base: $73,600.00 - $110,400.00 usd; bonus/equity: ...
Onsite
Experience with class ii and iii medical devices
Preparing fda 510(k) and pma submissions
Knowledge of eu mdr and iso standards
Medtronic Diabetes is seeking a Regulatory Affairs Specialist to support regulatory submissions and compliance for their neuromodulation products. The ideal candidate will have experience in the medical device industry, particularly with regulatory submissions for both the Americas and the EU

Job Summary

  • The role involves developing strategies for worldwide product registration and preparing submissions for the FDA, EU, and Canada.
  • Medtronic offers a competitive salary range of $73,600.00 to $110,400.00 along with comprehensive benefits including health insurance and 401(k) matching.
  • Employees are expected to work onsite 4 days a week at the Minnesota Rice Creek East facility to foster collaboration and innovation.

Matching Summary

Match Score: 85

Medtronic Diabetes is seeking a Regulatory Affairs Specialist to support regulatory submissions and compliance for their neuromodulation products. The ideal candidate will have experience in the medical device industry, particularly with regulatory submissions for both the Americas and the EU.

Salary

Base: $73,600.00 - $110,400.00 USD; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), Paid Time Off

Skills & Requirements

Must-have

  • Experience with Class II and III medical devices
  • Preparing FDA 510(k) and PMA submissions
  • Knowledge of EU MDR and ISO standards
  • Supporting license maintenance and audits
  • Reviewing labeling and device documentation

Nice-to-have

  • 2-5 years industry experience in regulatory roles
  • Advanced degree in scientific discipline
  • Experience with Agile project management tools
  • Exposure to device interactions with agencies
  • Strong cross-functional collaboration skills

Key Requirements

  • Bachelor's degree in scientific discipline with 2 years experience or advanced degree
  • Unrestricted US work authorization required at time of hire
  • Minimum 2 years relevant regulatory experience preferred

Work Rights

Must have unrestricted US work authorization

Tailored Resume

Cover Letter