Regulatory Affairs Medical Device Manager

[Your Tasks and Responsibilities]    

·       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.

·       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.

·       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 and Global Device Regulatory Affairs teams.

[Qualifications / Requirement]

·       PhD / Masters / Graduate in Engineering, Pharmaceutical, Chemistry or Biological Sciences.

·       3-5 years of proven South Korea regulatory experience in medical device industry, including hands on South Korea registration experience and direct working experience with MFDS and South Korea testing labs.

·       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.

·       Detail oriented and well-organized.

·       Motivated to work independently as well as with cross-functional teams.