Job Summary

• The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to market.
• This role involves providing expert advice on regulatory requirements, preparing and obtaining approval for FDA and EU submissions with multiple classification products that range from Class I to Class III in both regulatory environments.
• 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

Salary

Base: $92,000.00 - $138,000.00; Bonus/Equity: MIP; Benefits: Health, Dental, Vision, 401k, PTO

Skills & Requirements

Key Requirements

• Bachelor's degree or equivalent with 4 years of experience
• Direct experience in medical device industry
• Experience with Class III medical devices (PMA)
• Experience preparing and submitting regulatory filings to FDA, EU MDR
• Minimum 4 years of relevant experience

Work Rights