Senior Regulatory Affairs Specialist WATCHMAN

About the role:

At Boston Scientific well give you the opportunity to harness all thats 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 well help you advance your skills and career. Here youll be supported in progressingwhatever your ambitions.

Are you interested in working on cutting-edge technologies in the fast-paced cardiovascular medical device space At Boston Scientific youll 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 purposewhere we value diversity ensure everyones 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:

Bachelors 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:

Bachelors or Masters 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