Principal Regulatory Affairs Specialist

 

Additional Location(s): US-MN-Arden Hills; US-MA-Waltham

 

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:

At Boston Scientific, you’ll discover a place where you can have meaningful purpose—improving lives through your life's work. In our Rhythm Management (RM) division, we offer innovative solutions for treating irregular heart rhythms and heart failure, while protecting against sudden cardiac arrest. We continue to expand into new geographies and high-growth adjacent markets through cutting-edge technologies.

 

The Principal Regulatory Specialist will be responsible for planning, authoring, managing, and implementing regulatory submissions to the US FDA, EU Notified Bodies, and global regulatory agencies. This role supports worldwide product approvals and registrations, while ensuring continued compliance with regulatory requirements. It also includes change impact assessment, submission of updates, and ongoing maintenance of EU technical documentation.

Work model, sponsorship, relocation:

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:

● Provide regulatory guidance, training, and mentoring to Regulatory Affairs colleagues and cross-functional partners.

● Develop global strategies for regulatory approval across all medical device classifications.

● Coordinate, author, and submit U.S. and EU regulatory filings for new and modified products—including PMAs, PMA Supplements, pre-submissions, 510(k)s, CE Mark submissions under MDR, annual reports, and U.S. clinical investigation submissions.

● Support international submissions and registrations in partnership with BSC’s global regulatory teams.

● Respond to regulatory and clinical personnel requests related to international clinical investigation submissions.

● Build and maintain productive relationships with regulatory agency reviewers.

● Review technical and labeling documentation for regulatory submission readiness and compliance.

● Evaluate product and manufacturing changes for regulatory impact and ensure appropriate filing updates.

● Represent Regulatory Affairs on cross-functional project teams, including new product development and continuous improvement initiatives.

● Support and lead regulatory audits as needed.

● In all actions, maintain a primary commitment to patient safety and product quality by ensuring compliance with Boston Scientific’s Quality Policy and applicable procedures.

 

Qualifications:

 

Required qualifications:

● Bachelor’s degree in a scientific or technical discipline.

● Minimum of 7 years' experience in regulatory affairs or related field, or 5 years' experience with an advanced degree (Master’s or PhD).

● Proven knowledge of U.S. and EU regulatory requirements for medical devices, including clinical investigations and Quality Systems standards.

● Experience authoring a variety of regulatory submissions (510(k), PMA, CE Mark under MDR, etc.).

● Solid understanding of product development, clinical development, manufacturing, and change control.

● Strong problem-solving and research skills, along with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

 

Preferred qualifications:

● Previous experience in the medical device industry, specifically with Class II or III devices.

● Prior direct experience interacting with the FDA, Notified Bodies, or international regulatory authorities.

● Ability to work independently and manage multiple complex projects simultaneously.

● Demonstrated leadership, strategic thinking, and project management capabilities.

● Experience with capital equipment or software-based medical devices.

● Strong interpersonal skills and ability to clearly communicate complex regulatory concepts.

● History of providing technical guidance, training, or mentorship with