Regulatory Affairs Officer – MDR & Technical Documentation (Hybrid)

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

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.