RA Operation Manager

1. Support RA dossier verification check, publishing ,submission and archiving. Responsible for eCTD project development and implementation in future. 2. Lead system integration and implementation in China RA, not limited to regulatory information management system(PRISM ,Grace and MEDIVA), EQMS(MOSAIC and Sheds). 3. Product artwork system management, including label/PI double confirmation. 4. RA SOP management and SOP training monitoring. 5. Local Regulatory compliance support for RA team, perform gap assessment represent from China RA. 6. Establish and maintain regulatory intelligence for medical device, organize discussion for comments collection for the draft regulations. 7. Operation support for product IP, timeline update, product registration news ,RA access account etc. 8. Other assigned work from line manager。

职位描述

Madison Sun