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Boston Scientific · 1 month ago

Principal Regulatory Affairs Specialist

Arbor Lakes, MN

Full-time

Hybrid

Senior Level, Lead/Staff

$99K/yr - $188K/yr

5+ years exp

Boston Scientific is a leader in medical science, and they are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join their Interventional Cardiology and Vascular Therapies Division. In this pivotal role, you will ensure global regulatory compliance across various post-market surveillance domains and collaborate with cross-functional teams to drive compliance and continuous improvement.

Health CareMedicalMedical Device

No H1B

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

Qualification

Regulatory AffairsU.S. regulatory requirementsInternational regulationsPIR managementCAPA managementRegulatory submission softwareAnalytical skillsCommunication skillsInterpersonal skillsProject management

Required

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