Description
Hologic is hiring a Regulatory Affairs Specialist to manage moderate-complexity international regulatory projects for medical devices and in vitro diagnostics. The role covers global regulatory requirements, manufacturing, design, labeling, and post-market change assessments; preparation and maintenance of international submission dossiers and technical documentation; EU CE-Mark support; ROW submissions; review of validation and clinical materials; regulatory authority and customer relationship management; and guidance on compliant promotional materials. The position requires a life sciences or engineering bachelor's degree with at least four years of regulatory affairs experience, or a master's degree and/or RAC with at least one year of MDR/IVD regulatory experience, along with strong project coordination, communication, analytical, and technical-documentation skills.
