Job Description:
1. Responsible for arranging the registration plan of new products, tracking the registration process, including the collection, sorting, writing, declaration and progress tracking of registration information, and solving problems encountered in the research and declaration process;
2. Responsible for communicating with relevant government functional departments, including product testing departments, to ensure the smooth progress of the declaration;
3. Apply for and complete the production license of the product after obtaining the product registration certificate;
4. Tracked the changes of relevant laws, regulations and policies, updated them regularly, and completed the changes of listed products and the application for replacement of certificates;
5. Other relevant work arranged by the company and department.
Job Requirements:
1. Bachelor degree or above in clinical medicine, medical devices, biomedical engineering, mechanical and electrical engineering; More than 1 year working experience in the field of medical device industry registration regulations, regardless of gender and age; Experience in applying for class II active Medical Device registration certificate is preferred.
2. Familiar with the laws and regulations of the medical device industry and the registration procedures of the FDA; familiar with the requirements and relevant standards of the medical device quality management system. Familiar with the preparation rules of declaration materials, have the ability to independently prepare registration declaration materials;
3. Familiar with medical device product registration and inspection process;
4. Good English reading and writing skills, good team work and external communication skills;
5. Strong sense of responsibility and team spirit, able to keep technical secrets of the company;
6. Have good self-learning ability, and complete relevant work tasks assigned by leaders on time;