Regulatory Affairs Specialist. International Project. - ALTEN Delivery Centre Spain
hace 21 horas
Alicante
Are you looking for the next challenge in your career? Would you like to be part of an international, highly qualified team working on a strategic medical device market entry project in China? We are currently supporting a new project related to the Chinese market entry of a Continuous Glucose Monitoring (CGM) device, with a strong focus on regulatory activities and NMPA approval processes. Your benefits: • Competitive salary, • Long-term secure contract, • International project with the latest technologies, • Possibility of working remotely with a flexible schedule, • Integration in a highly qualified team of professionals, • Travel abroad with your project, • Specialized training and continuous professional development, • Social benefits and a flexible compensation plan Responsibilities: • Support regulatory activities for medical device approval in China (NMPA), • Manage and contribute to submission and approval processes, • Ensure compliance with Chinese regulatory requirements and applicable standards, • Prepare and review regulatory documentation (including Chinese-language documentation when required), • Collaborate with cross-functional international teams (Quality, Clinical, Product Development), • Provide regulatory guidance and support throughout the product lifecycle Requirements: • Proven experience in Regulatory Affairs in the medical device industry, • Strong hands-on experience with NMPA regulations and submissions, • Solid understanding of the Chinese regulatory landscape, • Experience with Class II and/or Class III medical devices is highly preferred, • Exposure to CGM, diabetes care, diagnostics, digital health, or wearables is a strong advantage, • Fluent English required (project language), • Chinese (Mandarin) is a strong advantage, especially for documentation, • German is a nice-to-have We positively value any international work or study experience. 📩 Please send your detailed CV in English.
Jose Ramon L.Activo hace 1 hora
