Regulatory Affairs Specialist 1 CR

Job Summary:

A Regulatory Affairs Specialist I, based at the Hologic Costa Rica site, who provides global regulatory support to cross-functional teams working on Hologic GSS products. This position serves as a key liaison between the Hologic GSS regulatory team and the Hologic Costa Rica manufacturing site, working to bridge communications and enhance cross-functional collaboration with local stakeholders. The position has primary responsibility for regulatory support and guidance for on market products manufactured at the Hologic Costa Rica site to ensure continued market access for medical devices. Works to ensure that regulatory requirements continue to be met and ensuring that documentation is current and accurate from a regulatory perspective. Responsibilities are performed through collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Quality, and Operations, and to ensure effective comm...