Medical Device Regulatory Specialist
Il y a 4 heures
Flemish Brabant, Flanders, Belgique
Michael Page (Belgium)
Temps plein
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ulliRegulatory Affairs, Medical Devices, MDR, EU MDR, Product Registration /liliProduct Lifecycle Management, Change Control, Regulatory Intelligence /li /ulh3About Our Client /h3pOur 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. /ph3Job Description /h3pAs a Regulatory Affairs Specialist, Medical Devices your responsibilities are: /pulliCoordinate medical device registrations across assigned international markets /liliPrepare, review and submit regulatory documentation with internal and external stakeholders /liliSupport regulatory compliance and manage changes throughout the product lifecycle /liliReview marketing materials and assess their regulatory implications /liliMonitor regulatory developments and communicate relevant updates internally /liliAct as a contact for manufacturers, distributors and competent authorities /li /ulh3The Successful Applicant /h3pA successful 'Regulatory Affairs Specialist, Medical Devices' should have: /pulliBachelor's or master's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related field /liliBetween 1 and 3 years of Regulatory Affairs experience within medical devices /liliGood knowledge of MDR, product registrations and regulatory documentation /liliProactive and organised, with strong analytical and communication skills /liliComfortable working with international teams and different stakeholders /liliFluent in English /li /ulh3What's on Offer /h3pOur customer offers you: /pulliA permanent contract with a competitive salary package /liliAttractive extra-legal benefits /liliInternational exposure within the medical device industry /liliStructured onboarding and development opportunities /liliThe possibility to build a long-term career in Regulatory Affairs /li /ul