Regulatory Affairs Specialist, Southern Europe

Location: Madrid, Spain OR Zaventem, Belgium

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. Our mission is to improve and save
lives through early detection of cervical and breast cancer, improved diagnosis,
and less invasive treatments.

We are looking for a Regulatory Affairs Specialist to join our Regulatory
Affairs EMEA team, taking ownership of regulatory activities across Southern
Europe.

What To Expect:

* 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.
* Serve as the primary contact with Competent Authorities in assigned
countries, supporting communications as needed.
* 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.
* Support regulatory activities for new product launches and introductions,
including participation in cross-functional core team meetings.
* Respond to regulatory inquiries from distributors, customers, sales,
marketing, customer service, and other internal stakeholders.
* 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, main

📌 Regulatory Affairs Specialist (España)
🏢 Hologic
📍 España