Regulatory Affairs: Intl Registrations & Market Access

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

Job summary

3ecruit seeks a Regulatory Affairs Officer to drive international registrations and market access from the Netherlands. You will manage dossiers, submissions and ongoing registrations across multiple markets, coordinating with internal teams, distributors and authorities worldwide.

The role requires knowledge of medical device regulations, EU MDR/UDI considerations, and proactive tracking of regulatory developments. Hybrid work is offered with English fluency required.

Qualifications

• Minimum 3 years' Regulatory Affairs experience in medical devices, dental devices, pharmaceuticals, biotechnology or a 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.

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.

Skills

Regulatory affairs

International registrations

English fluency

Project management

Regulatory submissions

Education

Bachelor's or Master's in Life Sciences or related field

Job description

3ecruit seeks a Regulatory Affairs Officer to drive international registrations and market access from the Netherlands. You will manage dossiers, submissions and ongoing registrations across multiple markets, coordinating with internal teams, distributors and authorities worldwide.

The role requires knowledge of medical device regulations, EU MDR/UDI considerations, and proactive tracking of regulatory developments. Hybrid work is offered with English fluency required.