[¿Ü±¹°è Top ÀÇ·á±â±â±â¾÷] RA Specialist
´ã´ç¾÷¹« - - Responsible for the coordination and preparation of document packages for regulatory submissions.
- - Monitors and improves tracking/control systems.
- - Keeps abreast of regulatory procedures and changes.
- - May direct interaction with regulatory agencies on defined matters.
- - Ensures rapid and timely approval on medical devices and continued approved status of marketed medical devices.
- - Ensures compliance with regulations and interpretations
ÀÚ°Ý¿ä°Ç - - Bachelor Degree
- - 3 ~5 years of relevant experience
- - Experience in multinational medical device companies preferred
- - Proficient English
- - Strong knowledge in of regulatory affairs in medical device, healthcare business and/or environment
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