-With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for product license applications and KGMP license applications; and coordinate the local testing and KGMP inspection related to the applications as needed.
-Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval and proper maintenance for new and/or existing licenses.
-Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for South Korea as per required timelines to the Global Regulatory Affairs teams.
-Review the device labelling materials to ensure the compliance to local labelling requirements.
-UDI registration/change update in local health authority system.
-Monitor and communicate the new or updated regulations from South Korea, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of South Korea are kept up to date in database systems.
-Develop and maintain tracking of regulatory device activities, including submission prioritization, submission status tracking and submission dossiers archiving (e.g. RIMS).
-Support Regulatory device internal process/SOP/KPI development and roll-out related to South Korea regulatory activities.
-Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advices from South Korea regulatory standpoint.
-Work in close collaboration, ensuring alignment and effective communication with APAC Device Regulatory Head, South Korea Commercial, Quality and Global Device Regulatory Affairs teams.