Regulatory Affairs Specialist. International Project

Puesto: Regulatory Affairs Specialist. International Project.
Location: Donostia / San Sebastián

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.