Fda, eu mdr, and global regulatory submission expertise
Knowledge of iso 14971 and iso 13485 standards
Medtronic is seeking a Senior Regulatory Affairs Specialist for their Pelvic Health Operating Unit, located in Rice Creek East, Minnesota. This role involves managing regulatory submissions and strategies for medical devices, particularly focusing on bladder and bowel control therapies
Job Summary
This role involves developing strategies for worldwide product registration and preparing submissions for FDA, European, and Canadian markets.
Medtronic offers a competitive salary range of $92,000.00 to $138,000.00 along with comprehensive benefits including health insurance and 401(k) matching.
The position requires working onsite 4 days a week at the Minnesota Rice Creek East facility to foster collaboration and innovation.
Matching Summary
Match Score: 85
Medtronic is seeking a Senior Regulatory Affairs Specialist for their Pelvic Health Operating Unit, located in Rice Creek East, Minnesota. This role involves managing regulatory submissions and strategies for medical devices, particularly focusing on bladder and bowel control therapies.
Salary
Base: $92,000.00 - $138,000.00 USD; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), Paid Time Off
Skills & Requirements
Must-have
Direct experience with Class III medical devices
FDA, EU MDR, and global regulatory submission expertise
Knowledge of ISO 14971 and ISO 13485 standards
Experience with PMA filings and license maintenance
Ability to interact directly with FDA and international agencies
Nice-to-have
Engineering or cybersecurity software AI experience
Advanced degree in scientific discipline
Experience in regulated biotechnology environment
History of successful device submissions
Strong negotiation and communication skills
Key Requirements
Bachelor's degree in scientific discipline with 4 years experience