Regulatory Assistant Engineer

Job Responsibilities:
1. Assist the supervisor in establishing the quality management system for production and operation;
2. Assist the supervisor in conducting internal and external audits and providing relevant training;
3. Assist the supervisor in completing product registration, changes, and extensions, etc.;
4. Participate in quality management meetings, handle and collect relevant adverse events;
5. Be responsible for the management of document control materials;
6. Complete other tasks assigned by the supervisor. 


Job Requirements:
1. More than two years of experience in registration or system management in the medical device industry, familiar with the registration of domestic Class II and Class III medical devices;
2. With ISO 9001, 13485 and MDR internal auditor qualification certificates preferred;
3. Bachelor's degree or above, with a relevant major (biology, pharmacy, laboratory science, computer, mechanical and management, etc.).

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