Senior Regulatory Affairs Strategist – Medical Devices

Boston Scientific Corporation; California; Hybrid; USD 107,000 - 203,000; Full time

Job summary

Boston Scientific Corporation seeks a Principal Regulatory Affairs Specialist to join our Neuromodulation Regulatory Affairs team. You will lead regulatory strategies and oversee submissions to FDA, EU notified bodies and global authorities while collaborating with cross‑functional partners to advance innovative medical devices.

This role supports global product registrations, ensures compliance for design and manufacturing changes, and drives continuous improvement of regulatory processes.

Qualifications

• Minimum 5 years' experience in regulatory affairs or related medical device field.
• Experience authoring or supporting U.S. and EU regulatory submissions (PMA/510(k)/MDR).
• Proficiency with common regulatory documentation and presentations.

Responsibilities

• Develop and manage regulatory submission strategies for medical devices.
• Coordinate U.S. and EU regulatory filings including PMAs, PMA supplements, 510(k), and CE submissions.
• Collaborate with cross-functional teams on product registrations and approvals.
• Support policy and procedure improvements within the department.
• Provide regulatory training to cross-functional teams.
• Lead projects related to product development and manufacturing changes.
• Review labeling and promotional materials for regulatory compliance.
• Assist in audits and inspections.
• Interact with international regulatory teams to maintain registrations.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Project management

Documentation & writing

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

Boston Scientific Corporation seeks a Principal Regulatory Affairs Specialist to join our Neuromodulation Regulatory Affairs team. You will lead regulatory strategies and oversee submissions to FDA, EU notified bodies and global authorities while collaborating with cross‑functional partners to advance innovative medical devices.

This role supports global product registrations, ensures compliance for design and manufacturing changes, and drives continuous improvement of regulatory processes.