EU MDR Regulatory Affairs - Technical Docs (Hybrid)

3ecruit; Soest; Hybrid; EUR 50,000 - 65,000; Full time

Job summary

3ecruit is seeking a Regulatory Affairs Officer to support EU MDR compliance and Technical Documentation for medical devices. Based in the Netherlands (Soesterberg), you will coordinate TD inputs across R&D, Quality, Manufacturing and Clinical teams in a highly regulated environment.

In this intermediate level role, you will own regulatory projects, manage UDI lifecycle, and contribute to EUDAMED submissions, while working in a hybrid setup (3 days onsite, 2 days remote).

Qualifications

• Minimum 3 years' Regulatory Affairs experience in medical devices or regulated industries.
• Experience preparing and maintaining Technical Documentation.
• Working knowledge of medical device regulations and quality systems.
• Fluent written and spoken English; Dutch preferred but not essential.

Responsibilities

• Prepare, remediate and maintain Technical Documentation in accordance with EU MDR 2017/745 throughout the product lifecycle.
• Coordinate Technical Documentation inputs from R&D, Quality, Manufacturing, Clinical and other subject matter experts.
• Support UDI assignment, UDI lifecycle management and EUDAMED data submissions.
• Review regulatory compliance relating to product changes, design modifications, labelling and documentation updates.
• Support labelling and IFU compliance and assess the regulatory impact of associated changes.
• Perform regulatory impact assessments relating to MDR transition and post-market compliance activities.
• Monitor relevant regulatory developments, identify potential risks and provide practical regulatory guidance to internal teams.
• Independently manage regulatory projects, track actions and coordinate cross-functional activities through to completion.

Skills

Analytical skills

Attention to detail

Cross-functional collaboration

Regulatory knowledge

English language

Education

Bachelor's degree in Life Sciences

Master's degree in Regulatory Affairs or related field

Tools

EUDAMED

UDI management

Job description

3ecruit is seeking a Regulatory Affairs Officer to support EU MDR compliance and Technical Documentation for medical devices. Based in the Netherlands (Soesterberg), you will coordinate TD inputs across R&D, Quality, Manufacturing and Clinical teams in a highly regulated environment.

In this intermediate level role, you will own regulatory projects, manage UDI lifecycle, and contribute to EUDAMED submissions, while working in a hybrid setup (3 days onsite, 2 days remote).