Job responsibilities:
1. Responsible for organizing the writing and modification of product technical requirements;
2. Responsible for communicating and following up with various functional departments within the company during the preparation process of registration application materials, and timely reporting the progress of various work to the registration supervisor;
3. Responsible for organizing the drafting, translation, and proofreading of registration application related materials;
4. Responsible for maintaining registration certificates, such as changing, correcting errors, and filing instructions for registration certificates;
5. Responsible for formulating work plans based on the review opinions of the drug regulatory department and being able to organize various functional departments to carry out work, ensuring timely obtaining of registration certificates;
6. Responsible for the circulation and payment of service contracts with third-party companies, and following up on contract execution;
7. Responsible for specifying the inspection plan; Complete the preparation and submission of testing samples according to the plan, follow up on the testing progress, and ensure timely receipt of testing reports;
8. Manage product registration documents in an orderly manner, and be responsible for archiving product information;
9. Responsible for researching and understanding domestic and international laws and regulations, providing basic consulting advice for product registration or certification
10. Provide relevant regulatory documents required for bidding in the company's business and sales departments;
11. Complete other tasks assigned by the registration supervisor.

Job requirements:
1. Bachelor degree or above, major in medicine, Biomedical engineering, electromechanical, materials, etc. is preferred;
2. Have experience in medical device registration; Overseas registration experience is preferred;
3. Understand the registration process;
4. CET-6 or above, good at listening and speaking, proficient in reading and writing; Work style is meticulous, rigorous, proactive, and organized, with a high sense of responsibility and a good team spirit. Proficient in operating commonly used office software.