Principal Regulatory Affairs Specialist

About the role:

Join our Interventional Oncology and Embolization team, where we create the next generation of cryoablation systems designed to treat abnormal tissue. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

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.

The Principal Regulatory Affairs Specialist is responsible for planning, managing and implementing regulatory submissions to the U.S. Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This role supports both new product development and ongoing compliance for a broad ablation portfolio, collaborating with cross-functional teams and international regulatory partners to ensure alignment and success.

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 in Maple Grove, Minnesota, 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:

● Represent the Regulatory Affairs function on cross-functional teams for new product development and sustaining activities, including manufacturing changes, site transfers and continuous improvement projects.

● Develop U.S. and EU regulatory strategies and prepare submissions for Class II medical devices.

● Create innovative regulatory pathways that support new technologies in collaboration with R&D, Quality, Operations, Medical Safety and Clinical teams.

● Prepare, coordinate and compile regulatory submissions, including IDEs, 510(k)s, EU MDR technical documentation and pre-submissions.

● Partner with international regulatory teams to support OUS registrations and post-market activities.

● Evaluate product and manufacturing changes for regulatory impact and ensure timely, compliant updates to filings.

● Lead interactions with the U.S. FDA and EU notified bodies to secure regulatory clearance and approval while ensuring alignment throughout the review process.

● Provide timely product and project information to global regulatory teams and communicate international requirements to project stakeholders.

● Foster effective relationships with regulatory agencies by delivering clear, strategic communications and follow-up.

● Apply strong project management and technical writing skills to drive regulatory deliverables across multiple initiatives.

Qualifications:

Required qualifications:

● Bachelor’s degree in a relevant scientific or engineering discipline.

● Minimum of 7 years' experience in Regulatory Affairs, or minimum of 5 years' experience with an advanced degree in a related discipline.

● Demonstrated leadership in regulatory strategy, project planning and cross-functional execution.

● Experience interpreting global regulatory requirements to ensure alignment with cost, schedule and performance goals.

● Proven ability to influence and negotiate with global regulatory authorities.

● Proficiency with U.S. and EU medical device regulations, including quality system standards and clinical investigation requirements.

● Strong understanding of the product lifecycle, including development, clinical studies, manufacturing and change control.

● Hands-on experience preparing IDEs, 510(k)s and EU MDR submissions.

● Excellent analytical, technical writing and communication skills.

● Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat.

Preferred qualifications:

● Direct experience submitting regulatory filings to the FDA, EU MDR and other global agencies.

● Deep knowledge of FDA regulations, EU MDR, MDCG guidance, ISO 13485, ISO 14971 and related global standards.

● Ability to work independently and mentor junior regulatory staff.

● Experience serving as the primary regulatory contact for the FDA and/or notified bodies.

● Proven ability to manage multiple projects and priorities effectively.

● Strong problem-solving mindset with a focus on quality, results and timely delivery.