Regulatory Affairs Officer - MDR & Technical Doccumentation

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

REGULATORY AFFAIRS OFFICER – MDR & TECHNICAL DOCUMENTATION

WHAT YOU WANT TO KNOW

• Location: Soesterberg, Netherlands
• Salary: €50,000 - €65,000, including holiday allowances based on x12.96 payment
• Hybrid: 3 days onsite - 2 days at home
• Department: Regulatory Affairs
• Level: Intermediate
• Permanent opportunity
• Fluent English required
• Dutch preferred but not essential

ROLE DETAILS

Join a global organisation specialising in advanced dental and medical device materials, supporting regulatory activities across a highly regulated international environment.

This role will focus primarily on EU MDR compliance, Technical Documentation and product lifecycle activities. You will work across Technical Files, labelling, UDI, EUDAMED and regulatory change assessments, while collaborating closely with R&D, Quality, Manufacturing and Clinical teams.

The position offers the opportunity to take ownership of regulatory projects and, over time, develop into broader global Regulatory Affairs activities including regulatory strategy, new product introductions and international expansion.

KEY 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

ESSENTIAL EXPERIENCE

• Minimum 3 years' Regulatory Affairs experience within medical devices, dental devices, pharmaceuticals, biotechnology or another regulated industry
• Experience preparing, maintaining or remediating regulatory Technical Documentation
• Working knowledge of medical device regulations and quality systems
• Experience supporting regulatory compliance and product lifecycle activities
• Strong analytical skills with excellent attention to detail
• Ability to independently manage regulatory activities while working across multiple functions
• Fluent written and spoken English

QUALIFICATIONS

• Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Chemistry, Materials Science, Regulatory Affairs or a related scientific discipline
• Knowledge of EU MDR 2017/745 is strongly preferred
• Experience with Technical Files, EUDAMED, UDI, labelling or IFU compliance is highly desirable
• Dutch language skills are beneficial but not essential