Sr. RA Specialist
Consultant Doris Dai
Date posted 20 April 2018No.1539 West Nanjing Road Shanghai 200040 Robert Walters China
It is a Global leading IVD company.
- Be responsible for registration dossier preparation and submission based on product launch planning and CFDA requirement.
- Be responsible for registration test protocol preparation and work closely with testing lab to perform the registration test based on registration planning and authority requirements.
- Communicate closely with the Headquarters on the needs and problems of registration documentation and registration test.
- Follow up closely with CMDE and NIFDC, and report the progress of product registration.
- Build good network with relevant governments such as CFDA, NIFDC, and testing labs.
- Bachelor’s Degree or above of Medical related major.
- 3-4 years experience on medical device or drug registration , preferably on IVD registration.
- Skill of performing testing in lab. Experience on R&D or Lab testing work is preferred.
- Good English & communication skills.
- Knowledge of GCP and CFDA guidelines.