Job Summary

• We are working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.
• 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.
• Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values.

Matching Summary

Salary

Base: $92,000.00 - $138,000.00; Bonus/Equity: Medtronic Incentive Plan (MIP); Benefits: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, Simple Steps, Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, Capital Accumulation Plan

Skills & Requirements

Key Requirements

• Bachelor's degree or equivalent with 4 years experience
• Advanced degree with 2 years experience
• 5-8 years industry experience
• 2-3 years regulatory, clinical, or quality roles
• Direct experience with Class III medical devices
• Experience with software-containing devices
• Experience with cybersecurity-relevant devices
• Proven experience preparing and submitting regulatory filings
• In-depth understanding of FDA requirements
• In-depth understanding of EU MDR
• Working knowledge of regulatory expectations for software
• Working knowledge of cybersecurity expectations
• Excellent negotiation, written, and oral communication skills
• Strong time management skills
• Ability to work independently

Work Rights