Sr Regulatory Affairs Spec

Medtronic Diabetes

Base: $92,000.00 - $138,000.00; bonus/equity: elig...
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Bachelor's degree with 4+ years experience
Master's degree with 2+ years experience
Medical device regulatory affairs experience
** Medtronic Diabetes is seeking a Senior Regulatory Affairs Specialist to manage regulatory activities related to medical devices, focusing on submissions like 510(k) applications and compliance with EU Medical Device Regulations. The ideal candidate will have extensive experience in regulatory affairs, particularly within the medical device industry. **

Job Summary

  • The Senior Regulatory Affairs Specialist will lead regulatory activities for the Basic Energy and Access and Instrument product portfolio at Medtronic Diabetes.
  • Candidates must have comprehensive experience across the entire regulatory life cycle of medical devices and a strong background in reviewing advertising materials.
  • Medtronic offers a competitive salary range of $92,000.00 to $138,000.00 along with a wide range of benefits including health insurance and 401(k) matching.

Matching Summary

Match Score: 75

** Medtronic Diabetes is seeking a Senior Regulatory Affairs Specialist to manage regulatory activities related to medical devices, focusing on submissions like 510(k) applications and compliance with EU Medical Device Regulations. The ideal candidate will have extensive experience in regulatory affairs, particularly within the medical device industry. **

Salary

Base: $92,000.00 - $138,000.00; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), PTO, Tuition assistance

Skills & Requirements

Must-have

  • Bachelor's degree with 4+ years experience
  • Master's degree with 2+ years experience
  • Medical device regulatory affairs experience
  • 510(k) submission preparation
  • EU MDR technical file knowledge
  • Promotional material compliance review

Nice-to-have

  • Design Dossier and Technical Documentation experience
  • International medical device submission experience
  • Project management systems knowledge
  • Agile methodology familiarity
  • SharePoint or Quality Management Systems
  • Experience with all product classifications

Key Requirements

  • Bachelor's degree plus 4+ years RA experience
  • Master's degree plus 2+ years RA experience
  • Unrestricted US work authorization required
  • No H-1B sponsorship available for this role

Work Rights

Must have unrestricted US work authorization

Tailored Resume

Cover Letter