Senior Regulatory Affairs Specialist - WATCHMAN

About the role:

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 advance your skills and career. Here, you’ll be supported in progressing—whatever your ambitions.

Are you interested in working on cutting-edge technologies in the fast-paced cardiovascular medical device space? At Boston Scientific, you’ll find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. This is a place where you can find a career with meaningful purpose—where we value diversity, ensure everyone’s voice is heard and respected, and prioritize initiatives that promote awareness and celebrate the personal, cultural, and demographic differences of our customers, patients, and workforce.

We are hiring a Senior Regulatory Affairs Specialist to support innovative growth initiatives within our Cardiology division, specifically the WATCHMAN Franchise. This high-impact role will drive regulatory strategy across next-generation technologies in Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), contributing to global submissions, MDR compliance, clinical initiatives, and new product development. This is an exciting opportunity for a regulatory professional with strong cross-functional problem-solving skills and a passion for software- and systems-based medical devices.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Weaver Lake Campus in Maple Grove, Minnesota and requires being on-site at least three days per week.

Relocation assistance:
Relocation assistance may be available for this position at this time.

Visa sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

● Develop and implement regulatory strategies for SaMD systems, ensuring compliance with U.S., EU, and global regulations
● Act as a core team member on new product development teams, providing regulatory guidance throughout product and manufacturing process development
● Prepare and submit global regulatory applications, including internal documentation and external filings
● Review and approve design and manufacturing changes for existing products to ensure compliance
● Partner with R&D, quality, manufacturing, clinical, marketing, and other functions to ensure regulatory success on complex software-driven projects
● Serve as company representative to regulatory agencies, managing written and verbal communication around submission strategies, testing, and follow-up
● Monitor and analyze competitive technologies and regulatory trends to guide business development and stakeholder alignment
● Provide technical guidance, mentorship, and regulatory training to peers and cross-functional teams

Required qualifications:

● Bachelor’s degree
● Minimum of 5 years' experience in Regulatory Affairs within the medical device industry, including experience supporting SaMD
● Solid understanding of SaMD concepts and regulations, including intended use, classification, multi-function device considerations, and AI/ML integration
● Experience compiling software documentation (requirements, architecture, risk analysis, V&V) for SaMD and both cloud-hosted and on-premise systems, including cybersecurity
● Thorough understanding of product development processes and design controls
● Proficiency in relevant U.S. and EU medical device regulations, including Quality Systems and clinical investigation requirements
● Demonstrated experience preparing a range of regulatory submissions for U.S. and EU (e.g., PMAs, PMA supplements, pre-subs, IDEs, 510(k)s, CE design dossiers, MDR tech files)
● Proven ability to manage multiple regulatory projects and serve as regulatory lead
● Strong technical knowledge of medical devices, procedures, and terminology
● Proficiency with Microsoft Office (Word, Excel, PowerPoint)
● Basic submission and presentation-related computer skills

Preferred qualifications:

● Bachelor’s or Master’s degree in Computer Science, Engineering, Biological Sciences, or related field
● Deep understanding of GMLP, FDA guidelines, and EU MDR requirements for AI-driven SaMD
● Familiarity with the IMDRF SaMD framework or similar software product development life cycles
● Experience in interventional cardiology and/or electrophysiology
● Strong clinical acumen
● Comprehensive knowledge of medical device standards and guidance documents
● Excellent research and analytical capabilities
● Strong organizational and communication skills; ability to synthesize and interpret technical input from various sources
● Leadership and influencing skills with experience mentoring others
● Ability to work independently with minimal supervision
● Experience with Class II and Class III medical devices