Recruitment
Recruitment Position
Number of Recruits
Salary Treatment
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Medical Device Registration
1
8-13K
Job responsibilities.
1、Responsible for the company's three types, two types of product registration of the overall planning, development of phase registration plan, and organize the implementation, complete the preparation of product registration information, product testing, system assessment, to obtain the product registration certificate;.
2、Responsible for contacting and communicating with relevant national and provincial drug regulatory bureaus and clinical research organizations, responsible for following up the progress of clinical trials and coordinating and solving problems in the clinical process.
3、Collect and organize the national registration requirements, track the changes of national and local medical registration policies, to ensure that the submitted registration materials comply with the policies and regulations.
4、Responsible for the maintenance of product registration certificates, including product registration certificate change and continuation, and related qualification certificates.
5、Effective management and maintenance of all product registration information, the establishment of product registration of the relevant document library.
Job requirements:
1, clinical medicine, pharmacy, nursing, medical devices, biology and other related professions;.
2, clinical medicine background, or engaged in clinical trial supervision, clinical trial management experience is preferred.
3, more than 5 years of relevant work experience, class III medical device clinical registration experience is preferred, familiar with medical device products CFDA certification and registration (familiar with CE and FDA can be a plus).
4, familiar with ISO13485, ISO9001 and other medical device quality system standards and regulations.
5、Familiar with the medical device industry related laws and regulations, policies, familiar with the workflow of government departments;.
6、Familiar with the declaration of the synthesis information writing, and have a good level of professional information writing.
Welfare treatment
1、Processing five insurance;.
2、The company provides free lunch for employees.
3、Paid vacation, holiday benefits, employee birthday party.
4、Private car free parking, battery car free charging.
5、Provide broad development space and promotion platform.
Contact Us
Email： info@disonmed.com
Address：No 67, Jinsuo Road,High-Tech Development Zone, ZhengZhou, 450001, Henan, China
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