RA Specialist
On-site · Seoul, Seoul, South Korea
Seoul, Seoul, South KoreaOn-siteFull TimeSenior LevelBachelors DegreeLarge
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Large
Job Summary
Regulatory Affairs Specialist responsible for Korea regulatory strategy and MFDS submissions, developing and executing regulatory plans, preparing high-quality dossiers, monitoring regulatory changes, and serving as the RA expert on cross-functional project teams to ensure alignment with MFDS regulations and ISO 20916 requirements.
Required Qualifications
- Bachelor's degree or higher in a relevant scientific field
- Minimum of 8 years of RA experience in the Korean medical device/IVD industry
- Expert knowledge of MFDS MD/IVD/Digital Medical Product regulations
- Experience with IVD / SaMD registration and clinical performance studies is highly preferred
- Proactive, self-motivated professional with strong strategic thinking and problem-solving skills
- Excellent written and verbal communication skills in Korean and English
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