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Medical Device Registration Specialist

Job Responsibilities:

1. Responsible for the registration of new products, including the entire planning process, data compilation, declaration and tracking;

2. Lead or participate in the establishment and maintenance of a quality management system based on the company's overall development needs;

3. Responsible for managing the entire process of medical device registration application, making it standardized and standardized;

4. Responsible for communication and coordination with external agencies related to product registration, such as testing agencies, clinical trial agencies, third-party certification agencies, drug regulatory departments, review centers, etc .;

5. Responsible for summarizing, classifying, sorting, and filing various regulations and technical standards issued by the drug supervision department;

6. Responsible for product production / operation license, change and renewal of product registration certificate.

job requirements:

1. Familiar with the laws and regulations related to the registration of Class II active instruments and Class III in vitro diagnostic reagents and related processes, and can independently complete Class II active instruments (such as dry fluorescent immunoassay analyzers) and Class III IVD detection reagents (fluorescent immunoassay) Law) registration work;

2. Maintain close ties with the drug supervision department, testing, certification, clinical and other related outreach organizations and establish good relations;

3. Possess good quality and professional ethics, communication ability, learning ability, teamwork ability, strong sense of responsibility, and strong stress resistance;

4. Major in clinical medicine, biology, pharmacy, etc., full-time undergraduate degree or above;

5. Familiar with the GMP quality management system of medical devices, with YY / T0287 internal auditor qualification.

Resume email: HR@neogene.net


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