Boston Scientific · 4 months ago
Senior Regulatory Affairs Specialist
Arden Hills US-MN, United States | N/A
Full-time
Hybrid
Mid, Senior Level
$83K/yr - $157K/yr
4+ years expBoston Scientific is a leader in medical science dedicated to improving lives through innovative medical solutions. The Senior Regulatory Affairs Specialist is responsible for planning and managing regulatory submissions to the US FDA and EU notified bodies, ensuring compliance with regulatory agency approvals, and supporting worldwide product registrations.
Health CareMedicalMedical Device
No H1B
Responsibilities
Develop global strategies for regulatory approval of all medical device classifications
Coordinate, author, compile, and submit U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, CE Mark submissions under MDR and US clinical investigation submissions
Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments and from clinical personnel related to international clinical investigation submissions
Develop and maintain positive relationships with regulatory body reviewers
Review Technical and Labeling documentation for inclusion in regulatory filings or as part of design changes
Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
Support regulatory audits, as required
In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
Qualification
Required
A minimum of a Bachelor's Degree
A minimum of 4 years of regulatory affairs or related experience
Demonstrated experience authoring a variety of regulatory submissions for US and EU
Computer skills, including experience with Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Preferred
Previous experience in the medical device industry with Class II or III device submissions
Experience working directly with FDA, notified bodies and/or international health authorities
Strong technical, research and problem-solving skills
Ability to articulate complex ideas clearly both verbally and in writing
Team player with excellent interpersonal and communication skills
Demonstrated ability to effectively manage multiple projects and priorities
Works well in fast-paced cross-functional team environment
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
2026-01-18
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