Regulatory Affairs Officer - MDR & Technical Documentation

Regulatory Affairs Officer – MDR & Technical Documentation

Utrecht area | €50,000–€65,000 gross/year | Hybrid working

We are recruiting a Regulatory Affairs Officer to join an established Regulatory Affairs team within an international medical device company based in the Utrecht area.

The role

You will help maintain 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 to keep technical documentation accurate, complete and up to date

Your profile

• Practical Regulatory Affairs experience within the medical device industry
• Hands-on experience managing and maintaining EU MDR Technical Documentation / Technical Files
• Experience assessing the regulatory impact of changes
• Fluent English
• Nederlands is een pluspunt, maar geen vereiste.
• You must already have the right to work in the Netherlands

Experience limited to international registrations, clinical documentation or pharmaceutical Regulatory Affairs does not meet the requirements of this role.

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 [email protected] for a confidential discussion, highlighting your experience with EU MDR Technical Documentation / Technical Files.

Only candidates meeting the key requirements will be contacted.

Check our offers on www.eurolondon.fr.