Summary of position : New product registration & Maintenance of existing product license Compliance with MFDS & Corporate QA requirements Management of internal/external KGMP audit/inspections as company representative. Document control: Device Master File, SOPs and Quality manuals Quality oversight of the storage and release testing of products Manage deviation and CAPA(Corrective Action Preventive Action) Focus person for any quality issues : Product complaints etc.DUTIES & RESPONSIBILITIESProduct registration: Prepare the document and manage the process for new product registration & maintenance/update of existing product licenses with MFDS Communicate with manufacturing sites to get the required documents and product dossiers Develop local language labeling when registering products Anticipate regulatory environmental changes and take appropriate actions to cope with the situation Participate in industry meeting and KFDA explanatory conferences actively, shares the information from above meeting with the team and other departments Verify the Korean text file for advertisements of the products developed by marketing teamQuality Assurance: Prepare for the successful KGMP on-site audit by MFDS/NB Prepare for the successful KGMP renewal by MFDS/NB in every three years Communicate with manufacturing sites to get the required documents and dossiers on time Prepare/revise/control local DMR and SOP to ensure compliance with the Corporate and the MFDS requirements for Dentsply Sirona Korea operation Adverse events reportingUDI: Experience of UDI (unique device identifier), UDI database and deep knowledge of MFDS requirements Experience with the design and implementation of a UDI for medical device units Label Verification: Ensure data accuracy between labels and master UDI data Data remediation: Compile data from various databases for entry into UDI database Advice on Reporting of medical device supply history with UDI
**À̷¼´Â Áö¿øÇϽô Æ÷Áö¼Ç¸íÀ» ±âÀçÇÏ¿© ±¹¿µ¹® À̷¼¸¦ ÇÑÆÄÀÏ·Î Á¢¼ö ºÎŹ µå¸³´Ï´Ù.
University/Bachelor¡¯s DegreeMore than 1 years experience in regulatory affairs of medical device or pharmaceuticalsUDI : Technical experience in a medical device or related field or previous internship and/or related consulting experience preferredFluent in EnglishNo reason for disqualification for oversea travels
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003