Assistant Regulatory Affairs Manager

Job description

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)