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 launchCommunicate 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 authorityOther Regulatory affair and compliance related work if needQualifications
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