Johnson & Johnson Careers

Assistant RA Manager(Mitek运动医学)

Beijing, China
Regulatory Affairs


Job Description

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.

Qualifications

Requirements

-        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 operating

Good time management 

Primary Location
China-Beijing-Beijing
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Regulatory Affairs
Requisition ID
1805643342W