The Principal Regulatory Affairs Specialist provides strategic leadership for the Core Respiratory product portfolio within the Acute Care & Monitoring unit
Job Summary
The Principal Regulatory Affairs Specialist provides strategic leadership for the Core Respiratory product portfolio within the Acute Care & Monitoring unit.
This role requires leading global regulatory strategies across the entire product lifecycle, from early development to business wind-down activities.
Medtronic offers a competitive salary range of $120,000 to $180,000 along with comprehensive benefits including health insurance and 401(k) matching.
Matching Summary
The Principal Regulatory Affairs Specialist provides strategic leadership for the Core Respiratory product portfolio within the Acute Care & Monitoring unit.
Salary
Base: $120,000.00 - $180,000.00; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), Paid Time Off
Skills & Requirements
Must-have
Bachelor's degree required
7 years relevant experience
Global regulatory strategy execution
U.S. Class I and II medical devices
EU MDR and ISO standards knowledge
Nice-to-have
Mentoring junior regulatory staff
Advertising material review expertise
Direct agency interaction experience
Solution-oriented professional mindset
Cross-functional collaboration skills
Key Requirements
Minimum 7 years of relevant experience
Bachelor's degree in related field
Unrestricted U.S. work authorization required
Expertise in 510(k) and PMA submissions
Knowledge of ISO 13485 and ISO 14971
Work Rights
Must have unrestricted US work authorization at time of hire