Johnson & Johnson Careers

Regulatory Affairs Specialist_Medical Devices

Beijing, China
Regulatory Affairs


Job Description

Requisition ID: 1905762905W

- 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
- 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.
Qualifications
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