JOB DESCRIPTION:

MAJOR RESPONSIBILITIES:

• Responsible for registration of medical device, IVDs and/or drug products.
• Responsible for the applications for New Product registration, variations of marketed products and license renewals within the set timeframe and conducting in compliance with NMPA/CMDE requirements as well as relevant internal SOP.
• Responsible for providing relevant regulatory supports to other company personnel
• Responsible for establishment of good working relationship with internal and external stakeholders to ensure effective product registrations.
• Adhere to internal SOP and RA working procedures

REQUIREMENTS:

• Bachelor or above
• Regulatory Affairs Specialist: 2 yr + Registration or clinical related experiences
• (Sr.) Regulatory Affairs Specialist: Minimum 4 years registration, clinical or regulatory policy and intelligence working experiences.
• Good English communication skill
• Work experience in multi-national company or government affiliates is a plus.
• Provide technical background and input to review cIFU and labeling translation.
• Ensure that product is compliance with all applicable regulation and Chinese national panel/industry standard.
• Sr. RA Specialist: Acknowledge the gap between NMPA regulation and EU/FDA regulation to establish the registration strategy.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

CRLB Core Lab

        

LOCATION:

China > Beijing : Canway Building

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable