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Regulatory affairs specialist. international project. (lérida)

Lérida
ALTEN Delivery Centre Spain
Publicada el 8 junio
Descripción

PbAre you looking for the next challenge in your career? /b /ppbr/ppbrWould you like to be part of an exciting highly qualified team of professionals in an international environment /pp?We are currently looking for a qualifiedb Regulatory Affairs Specialist /b /ppJoin an international division and work alongside with some of the most talented engineers and technicians from all over the world /ppbr/ppbr/ppb.brYour benefi /b /ppbr/pullits:brCompetitive Sal /liliary.Long-term secure contr /liliact.International Project with top technolo /liligiesPossibility of working remotely with a versátil sched /liliule.Integration in a highly qualified team of profession /lilials.Travel abroad with your proj /liliect.Specialized training and continuous professional developm /lilient.Social benefits and flexible compensation p /li /ulpbr/ppbr/ppblan.brResponsibil /b /ppbr/pulliities:brSupport and manage regulatory activities related to the registration and approval of medical devices in /lili China.Navigate and coordinate NMPA submission and approval pro /lilicesses.Ensure compliance with Chinese regulatory requirements and applicable sta /lilindards.Collaborate with cross-functional international teams, including Quality, Clinical, and Product Devel /liliopment.Provide regulatory guidance and risk assessment throughout the project li /li /ulpbr/ppbr/ppbr/ppbr/ppbfecyclebrR /b /ppbr/pulliequirementsbrProven experience in Regulatory Affairs within the medical devi /lilice industry.Hands-on experience with NMPA regulations, submissions, and approva /lilil processes.Strong understanding of the Chinese regulator /liliy landscape.Experience with Class II and/or Class III medical devices is highl /liliy preferred.Exposure to CGM, diabetes care, diagnostics, digital health, or wearable medical devices is a stron /lilig advantage.Fluent Engli /lilish required.Chinese language skills are a /lilistrong plus.German is considered a /li /ulpbr/ppbnice-to-havebrWe positively value all work or study exper /b /ppience abroad.All positions require a high level of English (at least B2) - please send your detailed C /ppbr/pV in English.

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