RA/QA Manager – STAAR China

OBJECTIVE AND MAIN TASK OF THE FUNCTION

1. Manage aspects of complaint handling team activities (including complaint handling and vigilance activities)
2. Act as STAAR China liaison with regulatory agencies including the NMPA and other governmental agencies, with respect to communications related to complaints, adverse events, and external audits/inspections. 
3. Ensure compliance to Global Quality System requirements, including but not limited to Training, Documentation, CAPA and NC handling, Risk Management, Field Action and Supplier Management and qualification
4. Support Global Regulatory Affairs team in preparing, reviewing, and maintaining medical device submissions to China NMPA
5. Monitor changes in Chinese regulations, NMPA guidance, GB/YY standards, and related requirements
6. Ensure timely submittal of adverse events to the NMPA.
 

TASKS

Quality Responsibilities:

1. Manage aspects of complaint ha...