Regulatory Affairs Officer: EU MDR & Technical Docs Lead

3ECRUIT; Soesterberg; Hybrid; EUR 50,000 - 65,000; Full time

Job summary

3ECRUIT partners with a global dental and medical device materials company to recruit a Regulatory Affairs Officer focused on EU MDR compliance, Technical Documentation, UDI, and EUDAMED. The role spans lifecycle activities, labeling, and regulatory change assessments with cross-functional collaboration.

You will own regulatory projects, monitor developments and advise on MDR transition and post-market activities.

Qualifications

• Minimum 3 years regulatory affairs experience within medical devices or a regulated industry.
• Experience preparing, maintaining or remediating regulatory Technical Documentation.
• Working knowledge of medical device regulations and quality systems.
• Dutch language skills are beneficial but not essential.

Responsibilities

• Prepare, remediate and maintain Technical Documentation per EU MDR 2017/745 across the product lifecycle.
• Coordinate inputs from R&D, Quality, Manufacturing, Clinical and other subject matter experts for Regulatory submissions.
• Support UDI assignment, lifecycle management and EUDAMED data submissions.
• Review compliance relating to changes, design modifications, labelling and documentation updates.
• Support labelling/IFU compliance and assess regulatory impact of changes.
• Perform regulatory impact assessments for MDR transition and post-market activities.
• Monitor regulatory developments and provide guidance to internal teams.
• Independently manage regulatory projects and coordinate activities to completion.

Skills

Analytical skills

Attention to detail

English proficiency

Education

Life Sciences degree

EU MDR knowledge

Job description

3ECRUIT partners with a global dental and medical device materials company to recruit a Regulatory Affairs Officer focused on EU MDR compliance, Technical Documentation, UDI, and EUDAMED. The role spans lifecycle activities, labeling, and regulatory change assessments with cross-functional collaboration.

You will own regulatory projects, monitor developments and advise on MDR transition and post-market activities.