Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): 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.

About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Interventional Oncology and Embolization division. In this role, you will play a pivotal role in supporting global regulatory compliance across key post-market activities, including Product Incident Reports (PIRs), Corrective and Preventive Actions (CAPAs), recalls, Nonconforming Events and Prevention (NCEPs), and audits. You will apply your knowledge of global regulatory requirements while collaborating with cross-functional teams and regulatory partners to support compliance, continuous improvement and effective regulatory execution.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. Work model, sponsorship: 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.

Your responsibilities will include: Serve as a Regulatory Affairs specialist and collaborate with the Field Action Team on product corrections and recalls. Manage communications with internal regulatory partners outside the U.S. and external regulatory bodies regarding recalls. Coordinate and manage Product Incident Reports (PIRs), including investigation, documentation and reporting to regulatory authorities. Develop and monitor Corrective and Preventive Actions (CAPAs) to address nonconformances and support continuous improvement within the divisional Regulatory Affairs group. Support regulatory activities associated with internal and external audits. Stay current on changes in regulatory requirements and trends and communicate relevant developments to key stakeholders. Provide regulatory guidance and support to cross-functional teams on post-market activities. Develop and deliver training programs on regulatory compliance topics for internal teams.

Qualifications: Required qualifications: Bachelor's degree in a scientific or technical discipline. Minimum of 5 years' experience in Regulatory Affairs and/or Quality within the medical device industry, including a minimum of 3 years' experience in Regulatory Affairs. In-depth knowledge of U.S. regulatory requirements and working knowledge of international regulatory requirements, including the European Union Medical Device Regulation (EU MDR) and other global regulations. Proven experience managing PIRs, CAPAs, recalls and audits. Proficiency with Microsoft Office and Adobe Acrobat, with the ability to work effectively with databases, document control systems and quality management software. Preferred qualifications: Advanced degree in a scientific or technical discipline. Strong analytical and problem-solving skills. Strong written and verbal communication skills, including technical writing and editing. Excellent interpersonal skills and demonstrated ability to collaborate effectively across teams. Ability to work independently and as part of a team. Ability to adapt to changing priorities and thrive in a fast-paced environment while meeting time-sensitive deadlines. Detail-oriented approach with strong organizational and project management skills. Demonstrated ability to use artificial intelligence tools to enhance efficiency, accuracy and decision-making, including regulatory research, document generation, data organization or workflow optimization, and a willingness to integrate AI into everyday work processes.