岗位职责:

Assessment Project handling (weight 80%)

1. Perform product assessment according to standard requirements, regulatory requirements, internal requirements, code of conduct.

2. Review technical documentation of the manufacturers and give the suggestion of certification decision.

3. Develop the technical capacity of the authorized product scope

4. Handle customer complaint or inquiry from competent authorities

5. Support sales and marketing activities in technical field

Operating support (weight 20%)

6. Support the daily operation of non-active medical device section

7. Perform other duties assigned by Department Manager

任职条件:

1. Master degree or above in Biology, Biotechnology Engineering, human medicine, Chemical Engineering, Material Engineering or the similar majors

2. Minimum 5 years working experience in the fields of medical device design/ regulatory

3. Working experience in quality system management is preferred.

4. Good communication and interpersonal skills

5. Diligence; strong teamwork spirit; self-motivation, and self-improvement

6. Can work independently and efficiently and work under pressure