Job Responsibilities:
1. Responsible for the collection and sorting of product registration laws and regulations, and provide a basis for the company's product registration process;
2. Responsible for sorting, writing and reviewing product registration materials;
3. Write or review clinical programs/reports, be responsible for the filing of clinical institution ethics and regulatory departments, track the whole process of clinical trials, collect results, and statistically analyze clinical data;
4. Responsible for the application of project registration materials, track the progress of the project, and solve problems encountered in the application process;
5. Responsible for the filing of registration materials.
6. During the registration process, timely and effectively communicate the progress with the company's superior leaders.
job requirements:
1. Bachelor degree or above in biology, genetics, laboratory, medical related major, rich experience in IVD product registration;
2. 3 years of work experience in in vitro diagnostic reagent research and development and registration application;
3. Familiar with the registration laws and regulations and registration process of medical devices and in vitro diagnostic reagents;
4. Strong communication and coordination skills, sense of responsibility, strong execution, and good teamwork spirit.
5. Those with relevant work experience in accounting and amplification in vitro diagnostic reagents are preferred.