OBJECTIVES/PURPOSE OF JOB
1. To carry out all necessary work to ensure the efficient and timely registration of products to be launched in China.
2. Initiate or give assessment for the QCR based on manager’s guide.
3. Keep contact with government, internal and external partners, solve problems about regulatory affairs (contain but not limited to customers complaints, local authority inspection, label review, etc).

KEY ACTIVITIES/RESPONSIBILITIES
1. Be familiar with and implement relevant Chinese laws, regulations, rules, specifications, mandatory standards and product technical requirements with the guide from manager, perform job responsibilities, ensure registration compliance, and take responsibility for the job
2. Be responsible for the registration of local and imported contact lens products with the guideline from manager, to ensure registration is processed as plan, including:
A．Coordinate with Marketing, Sales, Clinical Team and Global departments, to gather registration documents.
B. According to the relevant regulations and standard requirements, draft the product technical requirements（depends on product), follow up product test. Keep in touch with the test institutions closely with a good relationship. Ensure test can be proceeded smoothly.
C. Communication with NMPA, to ensure submission, technical review and administrative approval to proceed smoothly in each application. Tracking product registration process to make sure the certification getting on time.
D. To make necessary variation, correction, IFU-Updating after getting the registration certificate.
3. Learn and understand local/international regulation, conduct registration work and provide basic suggestions based on changed regulations.
4. Review the Chinese label and IFU according to NMPA’s requirements with manager.
5. Provide related document to Commercial, Sales, Supply Chain, IT departments, etc. Update product registration information in the internal system.
EDUCATION/QUALIFICATIONS/TRAINING
Education: Bachelor Degree or above
Major：English, Biology, Medical Device, etc. related，or more than 1 years of RA related experience
EXPERIENCE/ COMPETENCIES
1. 1 years of RA related experience
2. Pro-active at self-learning; good attitude with huge workload and high pressure: passionate, hardworking & patient;
3. Be honest and sense of process & team work; Strong oral & written English (CET band 6), PC skills, and communication skill;
4. Ability to work on multiple projects at the same time;
5. Flexibility and ability to adapt to change.
6. Abide by laws and disciplines, have good professional ethics and no bad employment record