Registered Specialist
classification:Campus Recruitment

Job Responsibilities:

1. Assist FDA, NMPA, CE registration matters, including application, planning, data preparation, declaration and tracking;

2. Participate in the R&D process of the technical department from the perspective of project registration, assist in handling design and development changes, and train the technical department on regulations and standards;

3. Responsible for external communication with external agencies related to product registration, follow up and promote product testing, registration testing, clinical trials, etc.;

4. Assist in the preparation and review of FDA, NMPA, CE and other national registration documents;

5. Keep an eye on relevant domestic and foreign laws and regulations and other relevant information, and make corresponding improvements based on the information;

6. Patent application matters, project applications at all levels, and trademark applications.

job requirements:

1. Bachelor degree or above in related majors;

2. With more than one year of medical device related work experience or project management experience, excellent fresh graduates are also acceptable;

3. Be able to independently complete the medical device registration application, and be familiar with the regulations and standards of the medical device industry;

4. Working experience in Class II and Class III medical device registration is preferred, ISO13485 internal auditor is preferred;

5. Proficiency in operating WINDOWS and OFFICE office software, with good expression skills, communication skills, organization and problem solving skills, and relevant professional English foundation.

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