Regulatory Affairs Specialist - Onsite

Medtronic Diabetes

Base: $74,400.00 - $111,600.00 usd; bonus/equity: ...
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Coordinate regulatory submission document packages
Lead license renewals and annual registrations
Recommend labeling and manufacturing changes
** Medtronic Diabetes is seeking a Regulatory Affairs Specialist to work onsite, focusing on regulatory submissions and compliance for medical devices related to pelvic health. The ideal candidate will have a relevant degree, experience in regulatory affairs, and a commitment to improving patient care through innovative solutions. **

Job Summary

  • The role involves directing coordination and preparation of document packages for regulatory submissions, internal audits, and inspections.
  • Candidates will recommend changes for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
  • Medtronic offers a competitive salary range of $74,400.00 to $111,600.00 along with comprehensive benefits including health insurance and 401(k) matching.

Matching Summary

Match Score: 75

** Medtronic Diabetes is seeking a Regulatory Affairs Specialist to work onsite, focusing on regulatory submissions and compliance for medical devices related to pelvic health. The ideal candidate will have a relevant degree, experience in regulatory affairs, and a commitment to improving patient care through innovative solutions. **

Salary

Base: $74,400.00 - $111,600.00 USD; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), PTO, Tuition assistance

Skills & Requirements

Must-have

  • Coordinate regulatory submission document packages
  • Lead license renewals and annual registrations
  • Recommend labeling and manufacturing changes
  • Monitor tracking and control systems
  • Keep abreast of regulatory procedures

Nice-to-have

  • Experience navigating quality management system
  • Medical device or drug change management experience
  • 510(k) and/or PMA submission experience
  • EU Medical Device Regulation (MDR) knowledge
  • Strategies for earliest clinical trial approvals

Key Requirements

  • Baccalaureate degree required
  • Minimum 2 years relevant experience
  • Unrestricted US work authorization required

Work Rights

Must have unrestricted US work authorization at time of hire

Tailored Resume

Cover Letter