Johnson & Johnson Careers

RA Specialist

Beijing, China
Regulatory Affairs


Job Description

Requisition ID: 1805651659W

Principal Duties and Responsibilities

Ø  Product registration related including new, change and extension:

·           Handling registration process, including

-        document requirement

-        sample ordering, type testing

-        dossier prepare

-        submit to SDA

-        follow up SDA evaluation procedure

-        solve various problems in whole process

-        file dossiers with consistent requirement

·           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

·           Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration

·           Paying attention to the market information such as the competitors’ with the analysis

Ø  To coordinate the post market surveillance project

Ø  Supporting Chinese IFU /labeling, copy review for product related

Ø  Maintain & Input database like: RA database, RTL…

Ø  Providing monthly report & analysis including latest registration status & post market surveillance

Ø  Develop Regulatory Strategy and Plan for Chartered R&D Initiatives from Sourcing Companies and Partner with the project team to ensure the approval at each review gate.

 



Qualifications

Requirements

-        Medical or related education background and knowledge

-        1-3 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
1805651659W