? Inspection and Reporting
- Independently interact with health authorities at different levels for routine/flight inspection activities to CooperVision including National Sampling program on yearly basis.
- Directly interface with customers/consumers for critical quality and compliance queries/issues resolving. Support authority inspections happened at customer side.
- Collaborate with local and global partners and lead the preparation of reporting as requested by health authorities e.g. annual reports, risk management reports, etc.
? Complaint and Adverse Events
- As primary contact, independently address and expedite product complaints from customers/consumers under CooperVision internal policy and procedures and ensures compliance with regulations. Ensure timely recording and reporting.
- Provide technical expertise to optimize complaint handling processes.
- Conduct AE monitoring, evaluation, and reporting in timely manner according to NMPA regulatory requirements and CV internal procedures. Ensure data is completely and accurately maintained and reported.
- Closely collaborate with global team for information exchange including local and oversea AEs.
- Prepare and submit Periodically Risk Evaluation Report (PRER) in time.
? Ad/Promo
- Conduct regulatory reviews including ECPs/HCPs and consumer interfacing ad/promo materials. Provide valuable guide and explore much friendly suggestions to support commercial desires.
- Handle ad/promo submissions based on commercial needs and ensure timely approval from regulatory authorities. Communicate with authorities for appeal as necessary.
? Others
- Ensure QMS is maintained in an efficient and effective manner, in particular those procedures/WI related to above mentioned scope. Identify process optimization opportunities from time to time and promote improvement activities.
- Identify potential regulatory compliance risks based on changes in regulations/standards, country specific matters or other unique characteristics.
- Conduct regulatory/quality trainings to CooperVision China staffs based on regulatory requirements and business needs to continuously promote quality and compliance awareness.
- Other regulatory compliance and quality assurance tasks as assigned by management.

• Solid knowledge of NMPA post market surveillance regulatory requirements especially GSP
• Independent problem solver, result-driven
• Patience and high sense of responsibilities
• Strong communication and interpersonal skills with both internal and external stakeholders
• Ability to learn product knowledge and basic technical materials
• Moderate in reading and writing in English
• Proficient knowledge of ISO 13485 is a plus