• First Application Engineer hire for a new US site in Washington, DC
• Long-term opportunity as the US team and capability scales
• High ownership role with real influence on how the US operation is built

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

REGULATORY AFFAIRS OFFICER – INTERNATIONAL REGISTRATIONS & MARKET ACCESS

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 from 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 multiple international markets.

This role will focus primarily on international registrations, regulatory submissions and global market access. You will work across registration dossiers, new product registrations, renewals, change notifications and ongoing registration maintenance.

The position will involve close collaboration with internal teams, distributors, regulatory representatives, consultants and authorities worldwide. Over time, there will also be the opportunity to develop into broader global Regulatory Affairs activities including regulatory strategy, Asia-Pacific Regulatory Affairs, new product introductions and international market expansion.

KEY RESPONSIBILITIES

• Prepare, compile and maintain regulatory registration dossiers for international markets
• Support new product registrations, renewals, change notifications and ongoing registration maintenance
• Coordinate regulatory submissions and ensure required documentation is prepared and maintained
• Track registration activities and provide clear progress updates to internal stakeholders
• Work with distributors, regulatory representatives, consultants and regulatory authorities across international markets
• Support EUDAMED activities and assess the impact of product, labelling and documentation changes on regulatory registrations
• Monitor global regulatory developments and assess potential impacts on products, registrations and market access
• Independently manage regulatory projects across multiple markets, identifying risks and driving actions through to completion

ESSENTIAL EXPERIENCE

• Minimum 3 years' Regulatory Affairs experience within medical devices, dental devices, pharmaceuticals, biotechnology or another regulated industry
• Experience preparing regulatory submissions and/or international registration dossiers
• Experience supporting international product registrations and market access activities
• Working knowledge of medical device regulations and quality systems
• Experience coordinating regulatory activities across internal teams and external stakeholders
• Strong organisational skills with the ability to manage multiple registrations, projects and priorities
• 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
• Experience with international regulatory frameworks such as FDA, Health Canada, TGA, PMDA, NMPA or ANVISA is highly desirable
• Knowledge of EU MDR 2017/745, EUDAMED and UDI requirements is beneficial
• Dutch language skills are beneficial but not essential

• Full training provided via senior member of the team
• Brilliant role for someone junior to grow their career
• Excellent technologies available in the AM industry 

• First Application Engineer hire for a new UK site in Swindon 
• Long-term opportunity as the UK team and capability scales
• High ownership role with real influence on how the UK operation is built