Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Join our Peripheral Interventions Team, where we create the next generation of cryoablation systems designed to treat abnormal tissue. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. This role will contribute to new product development efforts, including the next generation of cryoablation systems, while also ensuring ongoing compliance with regulatory agency requirements, such as conducting change impact assessments.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office in Maple Grove, MN at least three days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include :

• Support the development of domestic and international strategies for Class II medical devices
• Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including pre-submissions, 510(k)s, and CE Mark submissions under MDR
• Support international geographies to gain and maintain product approvals
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supporting regulatory audits, as required

Required Qualifications :

Preferred Qualifications :