Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

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 : The Principal Regulatory Affairs Specialist will lead the development and execution of U.S. and EU regulatory strategies to bring innovative Peripheral Vascular products-particularly drug-eluting devices-to market. This role supports both new product development and ongoing compliance for a broad vascular portfolio, collaborating with cross-functional teams and international regulatory partners to ensure alignment and success. As the primary Regulatory Affairs core team member for multiple Class III and Class II medical devices, you will drive regulatory submissions for combination products and contribute to the evolution of therapies that make a meaningful impact on patient lives. You'll work in a collaborative environment that encourages growth, functional excellence, and partnership across R&D, Clinical, Quality, and Operations.

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. Relocation assistance is not available 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 III and Class II medical devices, including combination products.
• 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 such as PMAs, PMA Supplements, IDEs, 510(k)s, EU MDR Technical Documentation, and pre-submissions.
• Collaborate with Clinical Affairs to generate and evaluate clinical and real-world evidence for regulatory submissions and study modifications.
• 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 U.S. FDA and EU Notified Bodies to secure regulatory clearance / approval, 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 :

Preferred qualifications :

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.