職位描述
職位職能:
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職位描述:
職位概述
International Draeger Graduate Program
崗位職責
Make annual approval plan for designated products with MKT/Sales
Well organize approval affairs, including ordering approval Demo/Sample from CS, requiring technical/legal documents from Manufacturer, draft approval standard, completing testing with support from Service/Manufacturing site, prepare and submit approval documentation to SFDA and responding questions from SFDA in a timely manner.
Complete product registration and re-registration according to approval plan
Fetch product license
Well communication with related interface to smooth product registration
Back up whole registration file, including technical documents from manufacturer, product std, IFU(EN&CH), application form and other legal documents(EN&CH) submitted to SFDA
Prepare and maintain an index of registration documents
Ensure its security and completeness
Active cooperates with RA/DD/SE for updating local/worldwide standards.
Contact manufacturer for technical/legal documents
Answer the questions during type testing and/or SFDA technical review
Contact MKT/Sales/CS for Demo and status of registration
Regular visit key interfaces of SFDA, e.g., technical review, standard control and registration supervision department
Other interfaces within or without Dr？ger
Support manager for collecting data, analyzing, sum & reporting and defining actions for improvement and other tasks assigned by Manager
Regular review the government website
.Check the standards applicability and inform manufacturer the applied standard
Prepare and maintain the applied standard list
任職條件
Bachelor degree and above with major in Biomedical Engineering or Medical Device Testing.
Excellent written and oral English.
At least 3 months Multinational Corporation company experience. Oversea education or working background is preferred.
