Marcast Levante SLU in Carrer Catalunya - Hiring Now

Regulatory Affairs Specialist. International Project. - ALTEN Delivery Centre Spain

1 day ago

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.