ABOUT THE ROLE
The successful candidate will be responsible for developing regulatory strategies and navigating the regulatory submission route map for South Korea. Reporting to the Country Manager, Korea and Regional RA Manager, Singapore, this role would be ideal for someone who is seasoned in maintaining effective QMS and submitting new product registration and renewals in compliance with Korean regulatory body requirements. This role provides the opportunity to play a key role in managing Medline Korea’s QMS and implementing its QA/RA strategies.

RESPONSIBILITIES

Regulatory Affairs:
• Prepare and submit KGMP and product registration documentation to support registration to Ministry of Food and Drug Safety (MFDS). Liaise with various departments and factories to obtain the documentation required. Ensure submissions are complete, properly formatted and comply with applicable regulatory requirements that lead to timely approval of new product registration in South Korea.
• Notify... and update Ministry of Food and Drug Safety (MFDS) of any changes of particulars/ documents related to product registration and KGMP licenses.
• Review and assess changes in existing products to determine for new registration and/or license revision. Work with cross functional team to assess and minimise impact to existing business.
• Maintain KGMP and product licenses approvals and update Regional HQ product listing database. Maintain all product registration submission dossiers (English and Korea version) in Regional HQ.
• Manage adverse events, field safety corrective action and UDI reporting to Ministry of Food and Drug Safety (MFDS) within the stipulated timeframe.
• Review and approve labels, advertising material to ensure compliance with approved claims and/or other regulatory requirements.
• Perform environment scan for new regulatory requirements and organize regulatory intelligence for impact assessment and update Regional RA.
• Support ad hoc request from distributors/ sales on product information (e.g: technical datasheet).

Quality Management System:
• Maintain the continuous effectiveness of the Quality Management System for Korea entity and ensure compliance to the Ministry of Food and Drug Safety (MFDS) regulatory requirements and align with Medline Corporate and Regional Quality Management System. Provide training of QMS all employees in Medline Korea.
• Perform internal audits for self-assessments as well as in the 3PL warehouse and facilitate inspections and audits from regulatory bodies or notified bodies.
• Identify improvements and inputs into the quality planning process.
• Support ad hoc request from distributors/ sales on product information (e.g: technical datasheet, vendor information).

Quality Activities:
• Receive the product quality complaints from distributors/ end users in Korea and collaborate with Regional Complaint Handling PIC for investigation and resolutions.
• Work with local Supply Chain to ensure incoming inspection are conducted in 3PL warehouse.
• Work with local Supply Chain and Regional QA to ensure any deviation/ reworks activities performed by 3PL warehouse are in accordance to Regional procedures and review the deviation/ rework performed. Regional QA to keep records of deviations and reworks in designated shared folders
Seoul South Korea

Salary Criteria