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.