Senior Medical Device Regulatory Affairs Specialist

Hologic in Cambridge seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions, audits, and lifecycle activities for medical devices across US, EU, and Canada. You will work with Regulatory Affairs, R&D, Clinical, Quality, Marketing and international teams to ensure compliance and timely product approvals.

The role requires strong technical writing, meticulous attention to detail, and experience with FDA/EU/Canada requirements; RAC or PM experience is a plus.

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