Senior Regulatory Affairs Specialist

 

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.       

 

Senior Regulatory Affairs Specialist
Vascular Therapies Division

About the role:

Join our Vascular Therapies Regulatory Team, where we develop innovative technologies to treat peripheral vascular disease. Our products improve patient outcomes and enhance lives by delivering some of the most advanced and comprehensive therapy solutions on the market.

 

As a Senior Regulatory Affairs Specialist, you will lead the development and execution of U.S. and EU regulatory strategies to bring and maintain innovative Peripheral Vascular products in global markets. This role supports both new product development and sustaining compliance across a broad portfolio, working cross-functionally with R&D, Clinical, Quality, and Operations as well as international regulatory partners.

 

As the Regulatory Affairs core team member for Class II and Class III medical devices—including combination products—you will drive critical submission activities and influence the evolution of impactful vascular therapies.

 

Work model, sponsorship:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our Maple Grove, MN 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:

● Support development of domestic and international regulatory strategies for Class II and III medical devices
● 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 collaboration with Boston Scientific’s global regulatory teams
● Evaluate product and manufacturing changes for regulatory impact and ensure appropriate filing updates
● Represent Regulatory Affairs on cross-functional project teams, including product development, manufacturing processes, and continuous improvement initiatives
● Support regulatory audits as needed
● Maintain a primary commitment to patient safety and product quality by ensuring compliance with Boston Scientific’s Quality Policy and applicable procedures

 

Required qualifications:

● Bachelor’s degree in a relevant scientific or technical field
● Minimum of 4 years' experience in Regulatory Affairs or a related discipline in the medical device industry (e.g., R&D, Quality, Clinical, Biocompatibility, Labeling)
● Demonstrated experience authoring or supporting a variety of regulatory submissions for U.S. and EU markets, including 510(k)s and MDR technical documentation
● 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
● Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat

 

Preferred qualifications:

● Experience with Class III combination products in both U.S. and EU regulatory environments
● Ability to work effectively in fast-paced, cross-functional environments
● Team player with strong interpersonal and communication skills
● Proven ability to manage multiple projects and competing priorities
● Strong problem-solving skills with a focus on quality, execution, and timely delivery

 

#LI-Hybrid

 

Requisition ID: 624469

Minimum Salary: $85000 

Maximum Salary: $161500 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see ww