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 

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)

[ 전형방법 ]
1차 서류전형
2차 면접전형

[ 제출서류 ]
국문.영문이력서.경력기술서 포함 (각종 증빙서류는 서류전형합격자에 한해 추후제출)
이메일: carly.lee@peoplework.co.kr
채용담당 : 이경아 전무 ( 02-6951-4931/ 010-2726-3565)

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