ph3Regulatory Affairs Specialist, Southern Europe /h3 h3Location: Madrid, Spain OR Zaventem, Belgium /h3 pHologic 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.
Our mission is to improve and save lives through early detection of cervical and breast cancer, improved diagnosis, and less invasive treatments.
/p pWe are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs EMEA team, taking ownership of regulatory activities across Southern Europe.
/p h3What To Expect: /h3 ul liManage 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.
/li liServe as the primary contact with Competent Authorities in assigned countries, supporting communications as needed.
/li liReview scientific and clinical literature to support product registrations and ongoing regulatory compliance.
/li liReview and approve documentation, labelling, and promotional materials to ensure regulatory compliance.
/li liMaintain accurate regulatory records and databases, in-country registration requirements, and product documentation files.
/li liMonitor current and upcoming regulations, standards, and guidelines impacting the business, and communicate key updates to the RA team.
/li liSupport regulatory activities for new product launches and introductions, including participation in cross-functional core team meetings.
/li liRespond to regulatory inquiries from distributors, customers, sales, marketing, customer service, and other internal stakeholders.
/li liProvide regulatory support for tenders, ensuring complete and timely responses to meet business deadlines.




/li liRepresent the Regulatory Affairs function in internal and external meetings, including industry association meetings, and take ownership of follow-up actions.
/li liProvide broader regional regulatory support, maintain shared platforms such as network drives and SharePoint, and report progress regularly to the RA EMEA team.
/li /ul h3What We Expect: /h3 ul li5+ years of professional experience in a Regulatory role within the life sciences industry, ideally within the medtech sector and product registration.
/li liFluent English and Spanish are essential.
Italian and Portuguese are an asset.
/li liStrong analytical skills and a high level of attention to detail.
/li liStrong problem-solving skills, with the ability to propose pragmatic, compliant solutions.
/li liProficiency in IT tools such as Outlook, Word, Excel, and PowerPoint.
/li liSelf-motivated, proactive, curious, and eager to learn.
/li liWell-organised and able to work independently while collaborating effectively with cross-functional and international teams.
/li liStrong oral and written communication skills, including the ability to communicate complex regulatory concepts clearly to non-regulatory stakeholders.
/li liWillingness to travel occasionally (approximately 10%).
/li /ul h3So Why Join Hologic?
/h3 pWe are committed to making Hologic a place where top talent comes to grow.
To support your success, we provide: /p ul liContinued development opportunities throughout your career, including exposure to regional and cross-functional initiatives.
/li liThe chance to directly impact women's health and patient outcomes across Southern Europe and beyond.
/li /ul pSalary: €40,000 – €50,000 gross per year /p pThe final offer will depend on experience, skills, and alignment with internal pay structures.
In addition, we offer a comprehensive benefits package including pension and insurances.
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📌 Regulatory Affairs Specialist (Montà)
🏢 Hologic
📍 Montà