Siemens Healthineers Pipeline position for (Sr)RA Specialist/RA Expert in Shanghai, China
Fast and efficient registration for responsible products and contribute the time to market. Responsible for all regulatory issues from pre and post market, take the lead for RA key project.
Areas of Responsibilities:
Work together with BL RA for all registration activities include testing, documents preparation, submission and achieve product license target in fast and effective way;
Maintain or develop good working relationship and cooperation with relevant authorities like test labs, CMDE etc. to improve working efficiency;
Provide regulatory support on both pre-market and post-market issues on responsible product lines;
Support market research on planned government and competition activities;
Deep research on regulation, standards and requirements and provide training to relevant partners;
Take the lead for the key and critical registration project.
Above 5 years (min.3 years in Siemens) in regulatory affair
good experience in medical device product registration, standardization
good experience in working with foreign company
Bachelor degree or above relevant in medical/ biological/engineering etc.
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