Regulatory Affairs Officers

Regulatory Affairs Opportunities

Join an international medical device company based in the Utrecht area as part of a dedicated team of three. This full-time, hybrid role offers a gross annual salary between €50,000 and €65,000, complemented by a 4% company bonus, a Defined Benefit pension plan, 30 days of annual leave, and up to two days of remote work per week after onboarding.

Product Lifecycle and EU MDR Compliance

One position focuses on maintaining regulatory compliance throughout the product lifecycle. Key responsibilities include:

• Maintaining and updating EU MDR Technical Documentation and Technical Files
• Assessing the regulatory impact of product, process, and documentation changes
• Collaborating closely with Quality, R&D, and Operations teams

International Registrations

The second position centers on maintaining product registrations across international markets. Core duties involve:

• Managing registrations, renewals, and change notifications
• Preparing and maintaining regulatory dossiers
• Tracking submissions across multiple countries
• Coordinating with local representatives and internal stakeholders

Required Profile

Candidates must possess hands-on Regulatory Affairs experience within the medical device industry. Ideal experience includes either EU MDR Technical File and Technical Documentation maintenance or international medical device registrations and submissions. Fluent English is required, while Dutch and other languages are considered an advantage.