Consultant Doris Dai
Date posted 20 April 2018No.1539 West Nanjing Road Shanghai 200040 Robert Walters China
Well comprehend relevant CFDA IVD reagent and instrument regulations, track the developments.
1 Well comprehend relevant CFDA IVD reagent and instrument regulations, track the developments.
2 Be responsible for import IVD reagent and instrument registration in CFDA.
3 Organise and implement registration tests and clinical trials.
4 Preparing product registration submission, tracking the process and obtain registration approval certificate as early as possible based on Registration Plan.
5 Necessary registration documents translation
6 Cooperate with manufacturer RA to get necessary registration information and data.
7 File and maintain registration documents.
8 Support to other functions on RA issues.
9 Have active and effective communication with relevant competent authorities
10 Executing other tasks assigned by QA&RA director.
1. Minimum 1 years working experience in medical device registration.
2. Working experience in IVD reagents and instruments registration in foreign company is a plus.
Bachelor's degree or above in Medical Inspection, Clinical Medical, Health-care, Biology, Life Science, Chemistry discipline or related