Boston Scientific · 4 weeks ago
Principal Regulatory Affairs Specialist
US-MA-Waltham
Full-time
Hybrid
Senior Level, Lead/Staff
$99K/yr - $188K/yr
7+ years expBoston Scientific is a leader in medical science, committed to solving important health industry challenges. The Principal Regulatory Specialist will be responsible for planning, authoring, managing, and implementing regulatory submissions to various global regulatory agencies, ensuring compliance and supporting worldwide product approvals.
Health CareMedicalMedical Device
No H1B
Responsibilities
Provide regulatory guidance, training, and mentoring to Regulatory Affairs colleagues and cross-functional partners
Develop global strategies for regulatory approval across all medical device classifications
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 partnership with BSC’s global regulatory teams
Respond to regulatory and clinical personnel requests related to international clinical investigation submissions
Build and maintain productive relationships with regulatory agency reviewers
Review technical and labeling documentation for regulatory submission readiness and compliance
Evaluate product and manufacturing changes for regulatory impact and ensure appropriate filing updates
Represent Regulatory Affairs on cross-functional project teams, including new product development and continuous improvement initiatives
Support and lead regulatory audits as needed
Qualification
Required
Bachelor's degree in a scientific or technical discipline
Minimum of 7 years' experience in regulatory affairs or related field, or 5 years' experience with an advanced degree (Master's or PhD)
Proven knowledge of U.S. and EU regulatory requirements for medical devices, including clinical investigations and Quality Systems standards
Experience authoring a variety of regulatory submissions (510(k), PMA, CE Mark under MDR, etc.)
Solid understanding of product development, clinical development, manufacturing, and change control
Strong problem-solving and research skills, along with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
Preferred
Previous experience in the medical device industry, specifically with Class II or III devices
Prior direct experience interacting with the FDA, Notified Bodies, or international regulatory authorities
Ability to work independently and manage multiple complex projects simultaneously
Demonstrated leadership, strategic thinking, and project management capabilities
Experience with capital equipment or software-based medical devices
Strong interpersonal skills and ability to clearly communicate complex regulatory concepts
History of providing technical guidance, training, or mentorship within Regulatory Affairs or cross-functional teams
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
$10.02B2025-02-21Post Ipo Debt· $1.58B
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
BioWorld Financial Watch
2025-12-25
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