Description

1. At least three years of registration experience in Class II and Class III related medical devices.

2. At least two years of registered project management experience.

3. There are internal and external audit related certificates.

4. Familiar with GMP and other relevant regulations of the medical device industry.

5. Strong ability to work under pressure, strong logical thinking ability, strong communication and coordination ability.

Job Responsibilities

1. According to the company's development plan, and the strategic layer to develop the product domestic registration project plan, and the registration project allocation and tracking.

2. New product registration, renewal and re-registration when registration expires.

3. Preparation and declaration of registration materials.

4. Maintain a good relationship with inspection agencies and third-party organizations and follow up the progress.

5. Communicate with the State Food and Drug Administration to ensure the smooth progress of the submission, review and approval of each registration application, track the product registration process in real time, and ensure that the certificate is obtained on time.

6. Receive and accompany the auditors to carry out the system audit work.

7. According to the requirements of the relevant laws and regulations of the "Medical Device Manufacturing Enterprise License", handle the application, change, renewal and other related matters of the enterprise production license, and conduct annual inspection and daily supervision of the production enterprise license and other certificates.

8. Prepare for flight inspection and various registration system audits.