Senior Regulatory Affairs & Compliance Specialist

JOB DESCRIPTION:

Overview

For the Abbott Rapid Diagnostics including Emerging Markets Business Mainland and HK. Fast and efficient registration and promotion of products to be sold in above territories. Support RA Manager in all activities.

Responsibilities

• Be responsible for registration/listing dossier preparation and submission based on product launch
• Communicate with legal manufacturer RA to prepare documents used for type testing.
• Perform registration type testing based on registration planning.
• Communicate registration regulation/requirement to related personnel.
• Good cooperation with the other colleagues of RA team and clinical trial team.
• Product labelling – ensure product labelling complies to NMPA regulatory requirements.
• Collate and submit product periodic risk evaluation report to local regulatory authority
• Other Regulatory affair and compliance related work if need

Qualifications

• Bachelor’s Degree of Medical related major. Clinical laboratory is preferred.

Competencies and Attributes

• Experience： Over 2-years of medical device registration experiences in China for imported product registrations. RA experience in IVD is preferred. 
• Competencies/Skills: Very accountable & detailed working attitude.  High integrity and team spirit.  Good English & communication skills. Proficient with Microsoft Office (Word, Excel, PowerPoint).

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:

ID Infectious Disease

LOCATION:

China > Beijing : Canway Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable