We are recruiting two Regulatory Affairs Officers for an international medical device company based in the Utrecht area.
We are looking for two complementary profiles to join an established Regulatory Affairs team.
1. Product Lifecycle / EU MDR
This position will focus on maintaining regulatory compliance throughout the product lifecycle, including:
- Maintaining and updating EU MDR Technical Documentation / Technical Files
- Assessing the regulatory impact of product, process and documentation changes
- Working closely with Quality, R&D and Operations
For this position, hands-on experience maintaining EU MDR Technical Documentation / Technical Files is essential.
2. International Registrations
This position will focus on maintaining medical device registrations across international markets, including:
- Registrations, renewals and change notifications
- Preparing and maintaining regulatory dossiers
- Tracking submissions across multiple countries
- Coordinating with local representatives and internal stakeholders
For this position, hands-on experience with international medical device registrations and submissions is essential.
Your profile
For both positions, you must have practical Regulatory Affairs experience within the medical device industry.
Candidates coming exclusively from pharmaceutical Regulatory Affairs without relevant medical device experience will unfortunately not be considered.
- Fluent English is essential
- Nederlands is een pluspunt, maar geen vereiste.
- You must already have the right to work in the Netherlands
Package
- €50,000–€65,000 gross/year, including 8% holiday allowance
- 4% company bonus
- Defined Benefit pension plan
- 30 days' annual leave
- Up to 2 days working from home per week after onboarding
Interested?
Please send your English CV to t.perriaux@eurolondon.com for a confidential discussion and indicate whether your experience is more aligned with EU MDR Product Lifecycle or International Registrations.
Only candidates meeting the key requirements will be contacted.
Check our offers on www.eurolondon.fr