Job Title : RA Specialist Company : Multinational Pharmaceutical company Location : Seoul Date : ASAP Responsibility: -Registration & Revision : IVD Reagents, Medical Devices -Mandatory Affairs : Product Technical documents update : Korean labeling : Managing Local QC test for manual IVDs : Mandatory report to KFDA (Import, Repair, Sales record) : Self-Audit & report the audit results to KFDA : Preparing Inspection by competent authorities -Managing and maintaining KGIP certification -Counterpart to Government bodies and Public Office concerning regulatory affairs -Supporting and controlling QMS (ISO) system -Managing local regulations Qualification: -Pharmacist License (Must) -Previous experience in regulatory affairs and quality management system -Good English skill -Good communication skill -General PC skill