Regulatory Affairs Officer

REGULATORY AFFAIRS OFFICER INTERNATIONAL REGISTRATIONS & MARKET ACCESS

WHAT YOU WANT TO KNOW

• Location: Soesterberg Netherlands
• Salary: 50000 - 65000 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

• Bachelors or Masters 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