Principal Regulatory Affairs Specialist
Boston ScientificMinnesota, United States
Posted December 1, 2025
99100 - 188300 USD year
Full Time
About the Company
Boston Scientific is a leader in medical science, committed to solving the challenges that matter most – united by a deep caring for human life.
Job Description
Boston Scientific is seeking a Principal Regulatory Affairs Specialist to join our Interventional Cardiology and Vascular Therapies Division. In this role, you will ensure global regulatory compliance across various post-market surveillance domains, including Product Incident Reports, Corrective and Preventive Actions, recalls, nonconforming events, and audits.
Requirements
- Bachelor's degree in a scientific or technical discipline; advanced degree preferred
- Minimum of 5 years' experience in Regulatory Affairs and/or Quality, with at least 2 years' experience specifically in Regulatory Affairs, preferably within the medical device industry
- In-depth knowledge of U.S. regulatory requirements, with strong preference for experience with international regulations, including EU MDR and other global frameworks
- Proven experience managing PIRs, CAPAs, recalls, and audit support
- Proficiency in regulatory submission software and databases
Benefits
- Generous Paid Time Off
- 401k Matching
- Tuition Reimbursement
- Relocation Assistance
