Principal Regulatory Affairs Specialist

Location
US-MA-Bedford
Last seen
Oct 15, 2026

About the role

Position Summary: This position is responsible for ensuring that pre‑market and/or post‑market regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in cross‑functional software development meetings; prepare software‑specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in...