Publicada el 18 junio
Misión del puesto
About the Role
Are you looking for the next challenge in your career? Would you like to be part of an exciting highly qualified team of professionals in an international environment? We are currently looking for a qualified Regulatory Affairs Specialist. Join an international division and work alongside some of the most talented engineers and technicians from all over the world.
Benefits
- Competitive Salary
- Long‑term secure contract
- International project with top 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 flexible compensation plan
Responsibilities
- Support and manage regulatory activities related to the registration and approval of medical devices in China.
- Navigate and coordinate NMPA submission and approval processes.
- Ensure compliance with Chinese regulatory requirements and applicable standards.
- Collaborate with cross‑functional international teams, including Quality, Clinical, and Product Development.
- Provide regulatory guidance and risk assessment throughout the project lifecycle.
Requirements
- Proven experience in Regulatory Affairs within the medical device industry.
- Hands‑on experience with NMPA regulations, submissions, and approval processes.
- Strong 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 wearable medical devices is a strong advantage.
- Fluent English required.
- Chinese language skills are a strong plus.
- German is considered a nice‑to‑have.
Additional Information
We positively value all work or study experience abroad.
All positions require a high level of English (at least B2) – please send your detailed CV in English.
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