Senior Regulatory Affairs Specialist - Vascular Therapies

Boston Scientific is seeking a Senior Regulatory Affairs Specialist to join our Interventional Cardiology and Vascular Therapies team. As a Senior Regulatory Affairs Specialist, you will be responsible for planning, managing, and implementing regulatory submissions to the US FDA and EU notified bodies, as well as supporting worldwide product registrations. This role requires a hybrid work model, and Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Requirements

• Support the development of domestic and international strategies for Class II and III medical devices
• Represent Regulatory Affairs on cross-functional projects
• Review and approve design and manufacturing changes for existing products
• Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products
• Support international geographies to gain and maintain product approvals
• Drive continuous improvement in department and divisional quality practices, collaboration, and knowledge sharing
• Support regulatory audits

Benefits

• 401k Matching
• Tuition Reimbursement
• Relocation Assistance
• Generous Parental Leave