We're hiring! | Regulatory Affairs Specialist (Dutch & English speaking)
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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 sciencesJunior 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 xqysrnh 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
Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.