Senior Regulatory Affairs Specialist

At Boston Scientific, we’re seeking a Senior Regulatory Affairs Specialist to plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and other global regulatory agencies. The role will ensure continued compliance with regulatory approvals by evaluating the impact of product and process changes.

Requirements

• Coordinate, compile, and submit U.S. and international regulatory filings for new and modified products
• Develop and execute domestic and international regulatory strategies for product approvals
• Maintain positive relationships with regulatory reviewers through proactive verbal and written communications
• Assess product and process changes for regulatory impact and ensure compliance with applicable regulations
• Represent Regulatory Affairs on cross-functional product development and clinical project teams, providing regulatory guidance throughout the product lifecycle
• Review and approve technical documentation and labeling for inclusion in regulatory submissions
• Participate in cross-functional initiatives, including process improvements and change management projects

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance