Regulatory Affairs Officers
Regulatory Affairs Officers – Two Positions
Utrecht area | Hybrid | Full-time | €50,000–€65,000
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 a team of 3.
1. Product Lifecycle / EU MDR
Your focus will be on maintaining regulatory compliance throughout the product lifecycle, including:
- Maintaining and updating EU MDR Technical Documentation / Technical Files
- Assessing regulatory impact of product, process and documentation changes
- Working closely with Quality, R&D and Operations
2. International Registrations
Your focus will be on maintaining product 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
Your profile
You have hands-on Regulatory Affairs experience within the medical device industry, ideally with experience in either:
- EU MDR Technical File / Technical Documentation maintenance, or
- International medical device registrations and submissions
- Fluent English is required. Dutch and other languages are an advantage.
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.
Only candidates meeting the key requirements will be contacted.
