HireDiversity

Beijing, CN

RA Specialist-000008KY

Description

? Product registration related including new and renewal
o Handling registration process for Gynecare products, including
? document requirement
? dossier prepare
? submit to SFDA
? follow up evaluation procedure
? sample ordering, type testing
? solve various problems in whole process
? file dossiers with consistent requirement
o Ensure to obtain the regulatory permits on time, in support of the organization's business requirements
o Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
? To coordinate the post market surveillance project
? Supporting Chinese IFU /labeling, copy review for product related
? Being involving into team working such as department meeting logistic arrangement
? Maintain & Input database like: RA database, RTL…
? Providing monthly report & analysis including latest registration status & post market surveillance

Qualifications


? Medical or related education background and knowledge
1~2 years experience in Regulatory Affairs

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Regulatory Affairs