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Regulatory affairs specialist. international project.

Ciudad Real (13080)
ALTEN Delivery Centre Spain
Publicada el 8 junio
Descripción

Are you looking for the next challenge in your career?Would you like to be part of an exciting highly qualified team of professionals in an international environment?We are currently looking for a qualified Regulatory Affairs SpecialistJoin an international division and work alongside with some of the most talented engineers and technicians from all over the world.Your benefi- ts:Competitive Sal- ary.Long-term secure contr- act.International Project with top technolo- giesPossibility of working remotely with a flexible sched- ule.Integration in a highly qualified team of profession- als.Travel abroad with your proj- ect.Specialized training and continuous professional developm- ent.Social benefits and flexible compensation plan.Responsibil- ities:Support and manage regulatory activities related to the registration and approval of medical devices in- China.Navigate and coordinate NMPA submission and approval pro- cesses.Ensure compliance with Chinese regulatory requirements and applicable sta- ndards.Collaborate with cross-functional international teams, including Quality, Clinical, and Product Devel- opment.Provide regulatory guidance and risk assessment throughout the project lifecycleR- equirementsProven experience in Regulatory Affairs within the medical devi- ce industry.Hands-on experience with NMPA regulations, submissions, and approva- l processes.Strong understanding of the Chinese regulator- y landscape.Experience with Class II and/or Class III medical devices is highl- y preferred.Exposure to CGM, diabetes care, diagnostics, digital health, or wearable medical devices is a stron- g advantage.Fluent Engli- sh required.Chinese language skills are a- strong plus.German is considered anice-to-haveWe positively value all work or study experience abroad.All positions require a high level of English (at least B2) - please send your detailed CV in English.

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