Principal Regulatory Affairs Specialist

bostonscientific • Maple Grove, MN

32d • $99,100 - $188,300 • Hybrid

About The Position

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.

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.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees