Johnson & Johnson Careers
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Assistant RA Manager(Mitek运动医学)
Requisition ID: 1805643342W
Principal Duties and Responsibilities
- Product registration related including new and renewal
· Handling registration processes for Mitek, including
n Document requirement
n Dossier preparation
n Submit to CFDA
n Follow up evaluation procedure
n Sample ordering, type testing
n Solve various problems in whole process
· Ensure to obtain the regulatory permits on time, in support of the organization’s business requirements
· Having a good and consistent communication with local marketing and known well the business plan especially product launch plan
· Figuring out a rational working registration plan
· Keeping all medical device relevant regulations in mind and having the own opinion on revision when necessary
· To coordinate the post market surveillance and recall with the written explanation if happening
· Working for product related copy review with the regulatory opinion
· Support Chinese IFU and labeling for product related
- 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
- Bearing part of new employee orientation training
- Maintain & input database like RA database, RTL…Provide monthly report & analysis including latest registration status & post market surveillance.
- Medical or related education background and knowledge
- 3-5 years Medical Device registration experience
- Good communication skill
- Better English and Chinese in writing and oral
- Well computer operatingGood time management
Johnson & Johnson Medical Shanghai Ltd. (7055)