Assistant Regulatory Affairs Manager

In compliance with the company’s compliance requirements and China’s regulatory requirements, fulfill the registration projects, certificate management, and document archiving of non-active implantable medical devices.

Main Responsibilities:

a. Registration and management of non-active implantable medical device.

b. Communicate and coordination with authority.

c. Track the regulatory trends and shandards changes.

d. Filing and management of registration documents.

Education/Experience/Qualifications:

a. Bachelor's degree or above in a science and engineering-related major Bilingual (English and Chinese). Master degree preferred.

b. >= 8 years or more of work experience in medical device registration, with at least 3 successful registration cases of Class III implantable medical devices and 2 active medical devices(project experience shall be provided as evidence)