Medical Device Regulatory Specialist
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- Regulatory Affairs, Medical Devices, MDR, EU MDR, Product Registration
- Product Lifecycle Management, Change Control, Regulatory Intelligence About Our Client Our client is an international healthcare organisation active in the medical device industry. The company develops and distributes products that support healthcare professionals and patient care across several international markets. To strengthen its Regulatory Affairs team, the organisation is looking for a Regulatory Affairs Specialist who will work closely with Quality, Clinical Affairs and other international stakeholders.
Job Description
As a Regulatory Affairs Specialist, Medical Devices your responsibilities are:
- Coordinate medical device registrations across assigned international markets
- Prepare, review and submit regulatory documentation with internal and external stakeholders
- Support regulatory compliance and manage changes throughout the product lifecycle
- Review marketing materials and assess their regulatory implications
- Monitor regulatory developments and communicate relevant updates internally
- Act as a contact for manufacturers, distributors and competent authorities The Successful Applicant A successful 'Regulatory Affairs Specialist, Medical Devices' should have:
- Bachelor's or master's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related field
- Between 1 and 3 years of Regulatory Affairs experience within medical devices
- Good knowledge of MDR, product registrations and regulatory documentation
- Proactive and organised, with strong analytical and communication skills
- Comfortable working with international teams and different stakeholders
- Fluent in English What's On Offer Our customer offers you:
- A permanent contract with a competitive salary package
- Attractive extra-legal benefits
- International exposure within the medical device industry
- Structured onboarding and development opportunities
- The possibility to build a long-term career in Regulatory Affairs If you would like to use your regulatory knowledge in the Life Science industry, please apply.
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