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. >= 5 years or more of work experience in medical device registration, with at least 1-2 successful registration cases of Class III implantable medical devices (project experience shall be provided as evidence)