Job description
1. Responsible for registration before the listing of domestic/international products, formulate registration plans, track the registration process, including the collection, finishing, writing, declaration, and progress tracking of registered materials to solve the problems encountered in the research and application process;
2. Responsible for the clinical research of clinical projects (including coordination and formulation of clinical experiment plans, selection of clinical research bases, clinical follow -up, clinical research progress and coordination, etc.); responsible for external communication and coordination of pre -clinical and clinical projects;
3. Assist the implementation and control of pre-clinical and clinical research projects; and be responsible for the teaching and management of CRA;
4. Responsible for the registration inspection and declaration of the product, including the inspection and acceptance, and the communication of the product testing department to ensure that the declaration work is smooth;
5. Solve the problems encountered during the declaration and the existing matters related to registration in the process of use;
6. Complete the filling of various statistics and investigation forms such as the pharmaceutical regulatory department on time;
7. Responsible for collecting and mastering the changes in policies, regulations and standards related to the company at home and abroad, update in time, accurately interpret, and announce the training of regulations, organizational internal regulations and standards;
8. Supervise and guide R & D personnel specifications to conduct research records and data output, and check and review;
9. Submit the monthly post work plan and summary according to the company's total planning, and make a monthly post;
10. Other tasks assigned by leaders.
Job requirements
1. Full-time Bachelor’s degree or higher in a key university with professional proficiency in biotechnology, medical device, and medical related majors;
2. Responsible for the collection of information on changes in international policies/regulations and internal training, conducts risk assessment of the existing quality management system, and adopts effective measures to mitigate regulatory risks;
3. Understands relevant international standards and regulations in the medical device industry, has 5 years of relevant work experience in medical device product registration and clinical experience; experience of three types of in vitro diagnostic reagents registration is preferred;
4. Professional proficiency in English, strong sense of responsibility, strong work ethic, and able to deal with problems with practical solutions.
5. Have good communication, coordination skills and teamwork spirit; strong learning skills, strong information retrieval skills;
6. Adapt to the rhythm of start-ups, and keep it highly consistent with the company's corporate culture and development; Have strong copywriting, smooth writing skills;
7. work carefully, meticulous, rigorous.