RA Medical Device Specialist 

[Tasks and Responsibilities(담당 업무 및 책임)]

-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. 

[Qualifications / Requirement(자격 및 요건)]

-Minimum Bachelor’s degree in Engineering, Pharmaceutical, Chemistry or Biological Sciences.
-5 years of proven South Korea regulatory experience in medical device industry, including hands on South Korea registration experiences both in Medical Electrical Equipment, Single Use Devices, and KGMP Certification; and direct working experience with MFDS and South Korea testing labs.
-Multinational company experience preferred.
-Familiar with local regulations and regulatory assessment of design changes.
-Experience multitasking in a deadline controlled and highly regulated environment.
-Proven ability to communicate effectively in Korean and English both verbally and in writing. 
-Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., MFDS.
-Good network with external stakeholders and local regulatory agencies.
-Detail oriented and well-organized.
-Motivated to work independently as well as with cross-functional teams.



근무 형태: 정규직

근무 요일/시간 5(~)

근무 지역서울특별시 영등포구 여의대로 108, 타워2 (파크원)

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