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SHL Senior Regulatory Affairs Specialist

Job Description

Mission:
Fast and efficient registration for responsible products and contribute the time to market. 

Responsibilities:
1. Work together with BL RA for all registration activities include testing, documents preparation, submission and achieve product license target in fast and effective way.
2. Maintain or develop good working relationship and cooperation with relevant authorities like test labs, CMDE etc. to improve working efficiency;
3. Provide regulatory support on both pre-market and post-market issues on responsible product lines; 
4. Coordinate and lobby in new regulation and standards related to medical device registration.

Education and Experience

·       Bachelor’s degree or above relevant in medical/ biological/engineering etc.

·       Above 5years in regulatory affairs of active medical device 

·       Experience in active medical device industry, include but not limited to product registration, R&D, clinical etc.




Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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