1. Promote the progress of product registration according to the registration plan.
2. Be responsible for the preparation of product registration and inspection data, communicate with inspection institutions on inspection matters, and coordinate the implementation of inspection work.
3. Be responsible for product registration and declaration, and organize the sorting of registration materials.
4. Communicate well with the drug administration to ensure effective communication and rectification of the problems in the issuance and supplement stage.
5. Coordinate the on-site system assessment of product registration and production license.
1. Bachelor degree or above, major in science and engineering, major in machinery, electronics and communication is preferred, and experience in mass spectrometry industry is preferred.
2. Be familiar with medical device regulations, such as GB 4793.1, gb14710, GB / t18268 medical device registration and filing management measures, etc. Have experience in active medical device registration projects, be familiar with registration materials and prepare relevant guidance documents.
3. Those who can complete class II and III Registration independently are preferred.
4. Have a sense of responsibility, work actively, be good at communication, have strong self-study ability, have good psychological quality, and be able to communicate independently with inspection institutes and regulators.
5. Be trained in laws and regulations related to medical devices, medical device registration and other relevant laws and regulations.