Job Description：

1. Responsible for the filing, continuation, registration, and change of medical device products related to the company;

2. Responsible for reviewing relevant technical documents in accordance with regulatory requirements, writing and organizing registration application materials;

3. Maintain good communication with relevant government departments and registration agencies, solve problems during the registration process, and ensure the smooth progress of registration work;

4. Timely collect relevant laws and regulations on medical device registration, as well as the latest developments in national industry standards for medical devices, to provide timely and effective registration support and relevant information for the company;

5. Complete other tasks assigned by the leader.

Job requirements：

1. Bachelor's degree or above in biotechnology, medical devices, or related fields;

2. Familiar with the regulations, standards, and procedures for medical device registration, familiar with the registration process for medical devices in China and CE, able to edit the required documents for Chinese registration and CE registration;

3. At least 2 years of experience in registering Class II or above passive medical devices, with successful cases;

4. CET-4 or above, excellent reading ability, solid writing foundation;

5. Familiar with ISO13485 quality management system documents.