Place of work:
Jiangsu Suzhou
Job responsibilities:
1. Responsible for the registration and tracking of active medical device products, including the collection, organization, writing, application, and progress tracking of registration information
2. Collect changes in national policies, regulations, and standards related to active medical device registration, and compile a summary report
3. Responsible for effective and good communication with government functional departments such as testing centers and evaluation centers
4. Responsible for assisting the R&D department in confirming that registered product research and verification meet regulatory requirements.
Job requirements:
1. Bachelor's degree or above in Biomedical Engineering, Electronic Communications, Medical Testing, Medical Devices, and related fields
2. Having complete experience in registering Class II active medical device products and familiar with the ISO13485 system
3. Familiar with the medical device registration process, with experience in writing product registration standards, preparing registration documents, contacting product testing, etc., able to independently undertake registration related work
4. Clear mind, agile thinking, possessing good oral and written expression skills, strong project coordination and communication skills;
5. Priority given to operators who have registered and certified electronic endoscopes, ultrasound equipment, high-frequency surgical equipment, and surgical machines for washing human beings
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