Beschreibung

Regulatory Affairs Officers – Two PositionsUtrecht area | Hybrid | Full-time | €50,000–€65,000We are recruiting two Regulatory Affairs Officers for an international medical device company based in the Utrecht area. We are looking for two complementary profiles to join a team of 3.1. Product Lifecycle / EU MDRYour focus will be on maintaining regulatory compliance throughout the product lifecycle, including: Maintaining and updating EU MDR Technical Documentation / Technical FilesAssessing regulatory impact of product, process and documentation changesWorking closely with Quality, R&D and Operations 2. International RegistrationsYour focus will be on maintaining product registrations across international markets, including: Registrations, renewals and change notificationsPreparing and maintaining regulatory dossiersTracking submissions across multiple countriesCoordinating with local representatives and internal stakeholders Your profileYou have hands-on Regulatory Affairs experience within the medical device industry, ideally with experience in either: EU MDR Technical File / Technical Documentation maintenance, orInternational medical device registrations and submissionsFluent English is required. Dutch and other languages are an advantage. Package €50,000–€65,000 gross/year, including 8% holiday allowance4% company bonusDefined Benefit pension plan30 days' annual leaveUp to 2 days working from home per week after onboarding Interested?Only candidates meeting the key requirements will be contacted.