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.