QRA Director--某外资体外诊断公司

 

Key Accountabilities:

 

Be responsible for the import medical device registration in CFDA.

 

Organize and implement registration tests and clinical trials.

 

Preparing product registering submissions, tracking the process and obtain registration approval certificate as early as possible based on Registration Plan.

 

Necessary registration document translation and check.

 

Cooperated with central RA to get necessary information and data.

 

File and maintain registration documents.

 

RA team work management and guide

 

Support to other functions on RA issues.

 

Min Knowledge & Experience required for the position:

 

Medical Laboratory Science /Medical Technologist, Bachelor degree 

 

Fluent Enligsh

 

Minimum 8 years working experience in registering, know the register process and policy.