Boston Scientific · 15 hours ago
Senior Regulatory Affairs Specialist - WATCHMAN
US-MN-Maple Grove
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $162K/yr
5+ years expBoston Scientific is a leader in medical science, committed to solving significant health industry challenges. They are seeking a Senior Regulatory Affairs Specialist to support innovative growth initiatives within their Cardiology division, focusing on regulatory strategy for next-generation technologies in Software as a Medical Device and Software in a Medical Device.
Health CareMedicalMedical Device
No H1B
Responsibilities
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
Qualification
Required
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
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
Benefits
Relocation assistance may be available for this position at this time.
Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.01B2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-02-04
Company data provided by crunchbase