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 versátil 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.
📌 Regulatory Affairs Specialist. International Project. (España)
🏢 ALTEN Delivery Centre Spain
📍 España
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