Regulatory Affairs Specialist_Medical Devices
Johnson & Johnson Family of CompaniesBeijingUpdate time: August 6,2019
Job Description
- Product registration related including new and renewal
o Handling registration process for CERENOVUS products, including
Document requirement
Dossier prepare
Submit to CFDA
Follow up evaluation procedure
Sample ordering, type testing
Solve various problems in whole process
TRD review and submission preparation
o Ensure to obtain the regulatory permits on time, in support of the organization’s business requirements
o Having a good and consistent communication with local marketing and known well the business plan especially product launch plan
o Figuring out a rational working registration plan
o Keeping all medical device relevant regulations in mind and having the own opinion on revision when necessary
o To coordinate the post market surveillance and Recall with the written explanation if happening
o Working for product related copy review with the regulatory opinion
o Supporting Chinese IFU and labeling for product related
o Compliance company policy, HCC and QA
o Participate the related standard and regulation conference/revision
o Having a good and consistent communication with local marketing and known well the business plan especially product launch plan
o Figuring out a rational working registration plan
o Keeping all medical device relevant regulations in mind and having the own opinion on revision when necessary
o To coordinate the post market surveillance and Recall with the written explanation if happening
o Working for product related copy review with the regulatory opinion
o Supporting Chinese IFU and labeling for product related
o Compliance company policy, HCC and QA
o Participate the related standard and regulation conference/revision
- Being proactive to participate the industrial activities to contribute the constructive suggestion
- Paying attention to the market information such as the competitors’ with the analysis
- Being involving into team working such as department meeting logistic arrangement
- Maintain & Input database like: RA database, MDRIM, RTL…
- Provide monthly report & analysis including latest registration status & post market surveillance.
Medical, laboratory or related education background and knowledge
2 Years Medical Device registration experience
Good communication skill
Better English and Chinese in writing and oral
Well computer operating
Good time management
Primary Location
China-Beijing-Beijing-
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Regulatory Affairs
Requisition ID
1905762905W
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