- The main work is to be responsible for product registration of certain product line, including new registration, renewal and change registration.
- Meanwhile the position is also responsible for some regulatory files monitoring and collection.
- 50% Ensure products are registered according to plans; oversee product registrations and maintain appropriate records for product compliance bodies (IVD directives, FDA requirements, Electrical Safety Regulatory, et al); 20%
- Ensure the change registration are done with regulatory analysis; 10%
- Ensure the monitoring of new regulations or regulatory files of certain authorities. 10%
- Ensure smooth and efficient communication with division RAs and local commercial team. 10%
- Ensure the good communication with related authorities.
Skills, Knowledge and Abilities (SKA):
- Work passion with positive thinking
- Good oral and written English
- Team Spirit
- Be able to work under pressure
- Bachelor degree or above in medical/biological/pharmaceutical majors.
- Master degree is preferential.