Under general direction from the QA functional lead, the position is responsible for regulatory compliance and quality assurance of CooperVision China through post marketing surveillance perspective. It covers key areas including authority inspection and reporting management, product complaint and adverse event management, Ad/Promo review, etc.
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.
Knowledge, Skills and Abilities:
- 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
Work Environment:
- General office environment
- Flexible hours to support the international nature of the job
Experience:
- 8-10 years working experience, with >5 years direct experience in regulatory compliance and quality assurance experience in medical device industry
Education:
Related majors (e.g. biological/chemical/pharmaceutical/material/etc.) is highly preferred
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