Job Description:
1. Responsible for the preparation of registration documents for medical device products (first registration, re-registration, change application and foreign registration), ensure to achieve CFDA,fDA, CE requirements;
2. Be responsible for the registration test, clinical trial new product clinical trial project tracking and data collation statistics, system examination and registration declaration and other work;
Responsible for the compilation of registration data such as product registration standards, specifications and technical documents, the filing and updating of registration data;
Coordinate the quality audit of products and company operation system;
Participate in the development, evaluation and implementation of quality control standards for new products;
6. Follow up the progress of the declaration, and solve the problems encountered in the process of product registration;
7. Be responsible for the coordination and project schedule management of the third party type test of new products;
8. Timely follow up domestic and foreign policies and regulations, update and feedback to relevant personnel, to ensure the smooth flow of information.
Job requirements:
Bachelor degree or above, major in pharmacy, clinical medicine, biology is preferred;
2. Yes Class II or III medical device products clinical, registered work experience, and can independently complete the whole process of new product registration system documents;
Proficient in ISO13485, ISO9001, GMP quality management standards, more than two years factory site management experience, have internal auditor qualification certificate is preferred;
Familiar with medical device related regulations and quality system standards, good communication and coordination ability;
5. Be familiar with the relevant regulations, regulations and registration process of national medical device registration, and be able to independently complete the writing, review,finishing, reporting and other work, and can track the registration process, solve the problems encountered in the application process;
Carry out the daily verification and measurement work;
7. Work hard, with high team spirit;
Eight Shaoxing locals or willing to long-term workers in Shaoxing.
Benefits: five insurance and one gold Employee Travel Year-end bonus Performance Bonus Professional training Flexible work Regular physical examination Salary negotiable
Working experience: 3-4 years
Minimum education : undergraduate