Regulatory Affairs Specialist, Southern Europe
Hologic is a leading developer, manufacturer, and supplier of diagnostic products, medical imaging systems, and surgical products, with a strong emphasis on serving the healthcare needs of women. We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs EMEA team, taking ownership of regulatory activities across Southern Europe.
Manage and maintain regulatory notifications and registrations for medical devices across all Hologic product lines in Southern Europe including in Greece, Spain, Portugal, Italy, and Malta.
Review scientific and clinical literature to support product registrations and ongoing regulatory compliance.
Review and approve documentation, labelling, and promotional materials to ensure regulatory compliance.
Maintain accurate regulatory records and databases, in‑country registration requirements, and product documentation files.
Monitor current and upcoming regulations, standards,



and guidelines impacting the business, and communicate key updates to the RA team.
Provide regulatory support for tenders, ensuring complete and timely responses to meet business deadlines.
Represent the Regulatory Affairs function in internal and external meetings, including industry association meetings, and take ownership of follow‑up actions.
Provide broader regional regulatory support, maintain shared platforms such as network drives and SharePoint, and report progress regularly to the RA EMEA team.
Fluent English and Spanish are essential. Italian and Portuguese are an asset.
~ Proficiency in IT tools such as Outlook, Word, Excel, and PowerPoint.
~ The chance to directly impact women's health and patient outcomes across Southern Europe and beyond.

📌 Regulatory Specialist and Senior Specialist (Madrid)
🏢 Hologic
📍 Madrid