Principal Regulatory Affairs Specialist

Boston Scientific is seeking a Principal Regulatory Affairs Specialist to join their Interventional Oncology and Embolization team. The successful candidate will be responsible for planning, managing and implementing regulatory submissions to the U.S. Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations.

Requirements

• Represent the Regulatory Affairs function on cross-functional teams for new product development and sustaining activities
• Develop U.S. and EU regulatory strategies and prepare submissions for Class II medical devices
• Create innovative regulatory pathways that support new technologies in collaboration with R&D, Quality, Operations, Medical Safety and Clinical teams
• Prepare, coordinate and compile regulatory submissions, including IDEs, 510(k)s, EU MDR technical documentation and pre-submissions
• Partner with international regulatory teams to support OUS registrations and post-market activities
• Evaluate product and manufacturing changes for regulatory impact and ensure timely, compliant updates to filings
• Lead interactions with the U.S. FDA and EU notified bodies to secure regulatory clearance and approval while ensuring alignment throughout the review process
• Provide timely product and project information to global regulatory teams and communicate international requirements to project stakeholders
• Foster effective relationships with regulatory agencies by delivering clear, strategic communications and follow-up
• Apply strong project management and technical writing skills to drive regulatory deliverables across multiple initiatives

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Medical, Dental, and Vision Benefits
• Employee Assistance Program
• Life Insurance
• Short-Term Disability and Long-Term Disability Insurance
• Paid Holidays
• Flexible Spending Accounts