Regulatory affairs specialist. international project.

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.