Hologic in Cambridge is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions, audits, and lifecycle activities for medical devices, with strong knowledge of US, EU, and Canadian requirements. You will collaborate across Regulatory, R&D, Clinical, Quality, Marketing, and international teams, review labeling and documentation, and ensure inspection-ready records.
You will manage regulatory databases, provide input on design reviews and manufacturing changes, and stay ahead
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Senior Medical Device Regulatory Affairs Specialist in Cambridge employer: Hologic
Hologic, Inc. is an exceptional employer that prioritises innovation and employee development within the healthcare sector. With a strong focus on advancing women's health, employees are encouraged to grow their skills in a collaborative environment while making a meaningful impact in the lives of patients. The Central North territory offers a dynamic market landscape, providing unique opportunities for sales specialists to thrive and build lasting relationships with healthcare professionals.
