Strategic Regulatory Affairs Lead – Medical Devices

Hologic is seeking a regulatory affairs professional to prepare and coordinate regulatory submissions, maintain technical files, and ensure compliance across US, EU, Canada and international markets. You will review labeling, marketing materials, user manuals, and product content for regulatory adherence, and support audits, inspections, and ongoing lifecycle activities.

The role requires collaboration with R&D, Quality, Marketing, and global partners, proficiency with regulatory databases, and

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