Senior Medical Device Regulatory Affairs Specialist

Hologic, Inc. in Cambridge, UK, is seeking a Senior Regulatory Affairs Specialist to support submissions, audits, and documentation for medical devices. You will collaborate with R&D, Quality, Clinical, and international teams to ensure regulatory compliance for US, EU, and Canadian requirements.

The role emphasizes maintaining technical files, labeling reviews, and proactive risk-based assessments, with a focus on product lifecycle activities and inspections readiness.