Boston Scientific · 10 hours ago
Senior Regulatory Affairs Specialist - Endoscopy
US-MA-Marlborough
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $170K/yr
4+ years expBoston Scientific is a leader in medical science committed to improving lives with innovative medical solutions. The Senior Regulatory Affairs Specialist will be responsible for developing regulatory strategies and supporting global compliance for the Endoscopy product lines, ensuring successful product registration and regulatory input throughout the product development lifecycle.
Health CareMedicalMedical Device
No H1B
Responsibilities
Develop and implement regulatory strategies for new and modified medical devices
Provide regulatory guidance for OEM and Contract Manufacturer partnerships
Act as a liaison for new business partners on US, EU, China, and international product registration
Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
Draft and submit U.S. and EU regulatory filings for new and modified medical devices
Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
Support associated global submissions in accordance with applicable regulations
Represent the company in communications with regulatory agencies regarding submission strategy, testing requirements, and follow-up during review
Support and maintain Boston Scientific's Quality initiatives in accordance with our Quality Policy
Continuously identify and support opportunities for quality improvement across the organization
Qualification
Required
Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline
Minimum of 4 years' experience in Regulatory Affairs within the medical device industry
Strong working knowledge of FDA, EU MDR, and international medical device regulations
Prior experience with 510(k) submissions
Prior experience with EU MDR
Prior experience with China and international regulatory requirements
General understanding of product development and design control processes
Familiarity with regulations related to the conduct of clinical trials
Fluent in Mandarin
Preferred
Experience preparing and submitting 510(k), PMA, IDE, EU MDR, or international registrations
Proficiency with Microsoft Office tools
Strong analytical, research, and problem-solving skills
Excellent written and oral communication, technical writing, and editing abilities
Demonstrated ability to work independently with minimal supervision
Ability to manage multiple regulatory projects simultaneously
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
2026-01-24
2026-01-23
Company data provided by crunchbase