|
[담당업무] ·Tasks
A leading global medical technology company is seeking a RAPA (Regulatory Affairs & Public Affairs) Manager for its Korea subsidiary, overseeing regulatory compliance for its medical device product portfolio (needles, syringes, IV catheters, prefillable drug-delivery systems, etc.).
Key Responsibilities
Lead RAPA strategy and policy execution in alignment with global standards and Korean regulations
Manage regulatory submissions, product registrations, variations, and renewals
Serve as primary contact for MFDS and notified bodies
Provide RAPA guidance to cross-functional teams (R&D, Commercial, Supply Chain)
Monitor regulatory changes and ensure timely implementation
Lead and develop a team of RAPA specialists
Manage RAPA budget and resources
Requirements
Bachelor's degree in a scientific field (Pharmacy, Biotechnology, Biomedical Engineering); Master's preferred
10–12 years of RA/PA/PV experience in the medical device industry, ideally with a major global pharma/medical device company
over 2 years of people management experience
Strong knowledge of MFDS regulations and international standards (ISO 13485, MDSAP, ICH-GCP)
Fluent in Korean and English (acts as a bridge with global HQ)
·
|
[자격요건] 경력: 경력 10년↑
학력: 대졸
직무기술: Strong knowledgeof MFDS regulations and internati
|
_118x46.png)
