Regulatory Affairs Director

1. Lead the registration team and be responsible for the registration of all products of the company, including import and domestic registration, new product registration, and the continuation and change of existing products.

2. Responsible for preparing relevant budgets.

3. Communicate with the relevant departments of the headquarters' registration regulations, coordinate and accelerate the speed of registering the group's products in China and ensure the accuracy of the application materials. Manage and track the progress of application, resolve technical and policy issues during the registration process, and ultimately ensure the successful registration of the product.

4. Timely grasp and familiarize with the latest national regulations on the registration and filing of medical device products and provide constructive opinions for management decision-making.

5. Communicate and maintain good relationships with government departments such as the National Food and Drug Administration and relevant testing centers to obtain relevant support.

6. Cultivate and guide team members, supervise them to complete the construction, archiving, and organization of medical device product registration and filing documents.

7. Other registration related matters.

8. Other tasks assigned by the general manager.