Regulatory Affairs Officer - MDR & Technical Documentation

Euro London Appointments Ltd; Utrecht; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

4% company bonus

30 days annual leave

Hybrid work | up to 2 days from home

Job summary

Euro London Appointments Ltd is seeking a Regulatory Affairs Officer for an established medical device company in the Utrecht area. You will maintain EU MDR Technical Documentation and assess regulatory changes across the product lifecycle.

Applicants should have hands-on MDR documentation experience and be eligible to work in the Netherlands. Collaboration with QA, R&D and Operations is essential for accurate technical files.

Qualifications

• Regulatory affairs experience in the medical device industry.
• Hands-on management of EU MDR Technical Documentation/Technical Files.
• Experience assessing regulatory impact of changes.
• Must already have the right to work in the Netherlands.

Responsibilities

• Maintain regulatory compliance throughout the product lifecycle.
• Maintain EU MDR Technical Documentation / Technical Files.
• Assess regulatory impact of product, process and documentation changes.
• Collaborate with Quality, R&D and Operations to keep technical documentation accurate and up to date.

Skills

Regulatory Affairs

EU MDR Documentation

Impact assessment

Netherlands work authorization

Job description

Regulatory Affairs Officer – MDR & Technical Documentation

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
• 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

• 4% company bonus
• 30 days’ annual leave
• Up to 2 days working from home per week after onboarding

Only candidates meeting the key requirements will be contacted.