Principal Regulatory Affairs Specialist

Location: US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Interventional Cardiology and Vascular Therapies Division
. In this pivotal role, you will ensure global regulatory compliance across various post‑market surveillance domains, including Product Incident Reports (PIRs), Corrective and Preventive Actions (CAPAs), recalls, nonconforming events, and audits. This position requires a strong understanding of global regulatory requirements and the ability to effectively collaborate with cross‑functional teams to drive compliance and continuous improvement.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Serve as a regulatory affairs specialist supporting product corrections and recalls in collaboration with the Field Action Team.
• Coordinate communication with internal OUS regulatory partners and external regulatory authorities for recall‑related activities.
• Manage Product Incident Reports (PIRs), including investigation, documentation, and timely reporting to regulatory bodies.
• Develop and monitor Corrective and Preventive Actions (CAPAs) to address non‑conformances and drive continuous improvement within the Regulatory function.
• Support regulatory activities related to internal and external audits.
• Stay current with evolving global regulatory requirements and trends, and communicate updates to key stakeholders.
• Provide regulatory guidance and support for post‑market activities across cross‑functional teams.
• Design and deliver training programs on regulatory compliance topics for internal teams.

Required qualifications:

• 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.

Preferred qualifications:

• Strong analytical and problem‑solving skills.
• Excellent communication and interpersonal skills.
• Demonstrated ability to work independently as well as collaboratively in cross‑functional teams.
• Comfortable adapting to shifting priorities and thriving in a fast‑paced, deadline‑driven environment.
• Detail‑oriented with strong organizational and project‑management capabilities.

Requisition : 619226

Minimum Salary: $99,100

Maximum Salary: $188,300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non‑exempt (hourly), non‑sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and…