Medical Device Registration Specialist

2022-06-29 18:23:09.763

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Minimum Education:

Undergraduate

Number of Recruits:

1

Experience requirements:

1-3 years

Work area:

山东省济南市高新区

Job Responsibilities:

1. Familiar with the process of registration and declaration of various medical device products;

2. Responsible for organizing the writing of clinical trial protocols and feasibility analysis of clinical trial protocols;

3. Responsible for the selection of clinical trial institutions, clinical trial applications, and related work such as filing;

4. Responsible for following up on the progress of clinical trials, promoting and providing feedback on issues, and coordinating and communicating with relevant clinical units and research institutions;

5. Responsible for monitoring and guiding clinical trials, and quality management of clinical trials;

6. Responsible for managing the processes of data collection, data management, clinical trial reports, and document archiving;

7. Responsible for establishing and improving the quality work specifications for clinical trials;

8. Follow up on updates to relevant national policies and regulations;

9. Timely feedback on comparative information between the declared products and similar products in the market;

10. Complete other tasks assigned by superiors.

 

Qualifications:

1. Bachelor's degree or above in medicine, nursing, pharmacy, or related fields.

2. Rich knowledge of clinical medicine and health statistics.

3. Strong communication and coordination skills, persuasion skills, and organizational planning abilities.

4. Good health, appearance, and temperament.

 

Work Location:

No. 6677, Lingang North Road, High-tech Industrial Development Zone, Jinan City, Shandong Province