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/AIn 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