Job purpose
To ensure company business objectives achieved through:
1. Initial registration and renewal the products of company
2. Report to SFDA about product change and get approval timely
3. Plan and implement internal audit to make sure compliance for both internal and external requirement on regulatory point of view

Accountabilities
1. Registering and renewing medical device licenses and other special approval on time as per the registration priority list.
2. Quality control the registration application and dossier, follow up the evaluation procedure, solve problem in registration.
3. Report product change to SFDA: Communication with HQ RA and report SFDA if there is any change on approved products, arrange gap time solution during the approval time.
4. Assist RA/QA manager for the registration affairs.
5. Support RA submission handled by distributors
6. Plan and implement internal audit to make sure compliance for both internal and external requirement on regulatory point of view

Requirement:
1. at lest 3 years experience with regulatory affairs for medical devices
2. bachelor degree on life science, bio-engineering, or relative
3. fully understand SFDA regulation on product registration, marketing supervision and etc
4. Good communication skill and interpersonal skill