RA Manager

Job description

 

Background:

  • Leading medical device manufacturers to offer innovative orthopedic medical devices and joint replacement

 

Job responsibilities:

  • Provide regulatory registration strategy for new product and change product
  • On-schedule premarket product registration, including registration plan, document preparation, testing, submission and response to CFDA questions
  • Collect Regulatory policy and intelligence 
  • Provide regulatory input into change control processes and activities
  • Provide regulatory support and collaboration to other functions 
  • Implement labeling procedure to ensure final product shipment to China 
  • Closely work with test lab, local FDA and CFDA review center to follow the status of submission cases 
  • Multiple projects management with balance priority and resource 

 

10 Oct, 2018
Beijing
Full Time
Zoe Luo
zoe.luo@lloydmorgan.com.cn
+86 512 6255 8576