Sr RA Specialist Job (Shanghai, CN)

Sr RA Specialist-00000IDV

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-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Regulatory Affairs