Sr. Regulatory Affairs Specialist

Job description

JOB DESCRIPTION:

主要职责 / MAIN RESPONSIBILITIES:

Responsible for local produced instrument, imported instrument and Reagents registration submission. Follow up with regulatory authorities on submissions and regulatory issues. Providing appropriate regulatory input to project team to ensure planned product development activities comply with the guidelines and provide a critical analysis of the risks and issues in case. Support to accept the quality system or facility inspection or product sampling inspection from each regulatory authority. Solve the complication from member and government requirement. Keep the good relationship with related authorization agencies such as with third-party certification institutes, Type testing institutes, regulatory technical review centers, and NMPA. Update the regulation and guideline to global RA on time. Provide the requested explanation and training to global or local cross group. Travel required during product registration and site meeting

任职要求 / QUALIFICATIONS:

Bachelor’s degree or above Above 2 working experience relevant RA Good English and communication skills.

     

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:

HIAC Core Lab

        

LOCATION:

China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable