About this role
International healthcare organization active in the medical device sector, supporting patient care through innovative products distributed across multiple global markets. Jobomschrijving As a successful Regulatory Affairs Specialist - Medical Devices - EN , you will have the following responsibilities: Coordinate product registrations across assigned international markets Prepare and submit regulatory documentation with internal and external stakeholders Support ongoing compliance activities for medical device portfolios Manage regulatory aspects of product changes throughout the lifecycle Review and assess regulatory implications of marketing materials Monitor regulatory developments and communicate relevant updates Act as a key contact for manufacturers, distributors, and authorities Contribute to continuous improvement initiatives within Regulatory Affairs As a successful Regulatory Affairs Specialist - Medical Devices - EN , you will have the following profile: Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or related field 1-3 years of experience in Regulatory Affairs within medical devices Strong knowledge of MDR requirements and registration processes Experience supporting product registrations and lifecycle activities Excellent communication and stakeholder management skills Proactive personality who actively seeks information and drives actions forward Comfortable collaborating with international stakeholders Fluent in English Strong analytical and organizational skills Team-oriented with a continuous improvement mindset