College or above /1-3 years experience in passive medical device registration preferred / full-time
1. Responsible for the coordination and supervision of clinical trials of medical device products;
2. Responsible for the drafting and tracking of medical device product standards;
3. Responsible for the sorting and registration of medical device products;
4. Responsible for the preparation and formulation of product standards;
5. Responsible for the preparation of clinical trial programmes, clinical statistics and clinical reports;
6. Responsible for the preparation and declaration of product registration information;
7. Responsible for tracking the progress of product declarations and solving problems encountered in the reporting process;
8. Responsible for the preparation of relevant information and coordinating with other departments to ensure the accuracy of reporting data;
9. Responsible for communicating with the medical product testing department to ensure the smooth progress of product registrations;
10. Participate in the clinical trials of products
1. Major in biomedicine, immunology, biological engineering, Bachelors degree or above;
2. Good communication skills and ability to review literature;
3. More than 2 years' experience in the registration of IVD products, and have prior experience in the R&D centre or manufacturing site about IVD products.
4. Familiar with the declaration process, and relevant laws and regulations of medical device and related product registration;
5. Familiar with the writing of report reviews and have good professional data writing skills; collect technical materials and prepare product declaration materials according to the requirements of the company; understand and report product registration policy and regulations;
6. Enterprise experience is preferred, and internal audit qualification is preferred.
7. Enthusiastic, practical and earnest, with a strong sense of self-motivation and responsibility. Good team player, good coordination and communication;
Interested parties can directly contact 010-80225661 during working hours: 9:00am - 9:00pm
College or above /1-3 years’ experience preferred / full-time
- Assist the project leader in the design of clinical trial programmes and CRF, the researcher's manual and relevant information, and assist in completing clinical trial summary reports.
- Responsible for the preparation, launch, implementation and analysis of clinical trials to ensure test progress, quality and compliance.
- Responsible for organizing and compiling declaration materials, including instruction manuals, pharmacological toxicology, clinical trial reviews, researcher manuals, etc.
- Assist in the screening of clinical trial centers, responsible for organizing various meetings druing clinical trials. Good communication skills needed to coordinate with research institute experts.
- Responsible for supervising work and people involved in the project
- Assist other departments to complete product registration, market promotion technical support, etc.
- Major in clinical medicine, clinical pharmacology, pharmacy, with a bachelor degree or above.
More than 2 years relevant working experience.
- Familiar with GCP related regulations and clinical trial SOP, proficient in writing clinical trial related documents.
- Strong English reading and translation skills, especially literature retrieval.
- Cadidates who have experiences in organizing conferences and are good at making PPTs are prefered .
- Hardworking, positive, able to work under pressure and willing to travel.
- Clear thinking, strong presentation skills and good communication skills.
The company is located at the Gaomidian South Station(Line 4) which is convenient for transportation.Interested parties can directly contact 010-80225661 or by WeChat: 18515927579