Regulatory affairs support junior (Ceuta)

We're hiring! | Regulatory Affairs Specialist (Dutch & English speaking)

Remote or Madrid (Hybrid options available)

We are currently looking for a Dutch-English (both fluent a MUST) speaking Regulatory Affairs Specialist to join our international team and support regulatory activities for our of our clients with a strong focus on Belgium and the Netherlands. This is a great opportunity to work in a highly collaborative, European environment with strong cross‐functional exposure.

Key Responsibilities

Dutch-specific responsibilities (Belgium & The Netherlands):

* Review and approval of promotional materials in Dutch, ensuring compliance with local regulatory requirements
* Monitoring, interpretation, and implementation of new and evolving regulatory regulations
* Regulatory support to multiple departments including General Management, Market Access, Marketing, and Quality

General regulatory support (English):

* Support with EUDAMED-related activities
* Assistance with Authorised Representative responsibilities
* Collaboration with cross-functional teams across different European countries
* Administrative regulatory support to the Netherlands Manager and European Manager, including:
* Updating regulatory databases
* Managing product registration and notification processes with competent authorities

Profile

* Fluent in Dutch and English (mandatory)
* Previous experience in Regulatory Affairs, ideally in medical devices, pharma, or life sciences Junior or post‐trainee profiles are welcome, given the Dutch language requirement
* Good understanding of European regulatory frameworks (EUDAMED knowledge is a plus)
* Highly detail-oriented, well organised, and comfortable working in a multi-country, matrix environment
* Strong communication skills and ability to interact with diverse stakeholders

Why join us?

* International exposure across several European markets
* Work in a dynamic and evolving regulatory environment
* Strong cross-functional collaboration
* Key role supporting regulatory compliance and business continuity

What we offer

* Gross annual salary (SBA): €30,000
* ️ Restaurant ticket
* Private medical insurance
* Language classes
* Hybrid or fully remote work model Postúlate en Kit Empleo: kitempleo.es/empleo/6t9c40