seoulhealthcare/regulatory-affairs2023-11-102024-01-06medical-and-nursing서울시Seoul Capital AreaKRRobert Waltershttps://www.robertwalters.co.krhttps://www.robertwalters.co.kr/content/dam/robert-walters/global/images/logos/web-logos/square-logo.pngtrue
An RA/QA Manager position is now available at a multinational medical device manufacturer. The selected candidate will oversee the quality management system's development and efficacy. This role is based in Seoul.
Facilitate site activities to meet regulatory goals, requirements, and submissions
Manage the design review processes
Analyse and assess industry standards for quality and regulatory requirement
Deliver feedback on project initiatives and performances
Act as a representative on inspections, audits, and investigations
Give comments on possible issues and challenges
Bachelor’s degree or equivalent in engineering or quality management
More than 6 years of medical devices or life sciences experience (electro-mechanical device organisation is a plus)
Prior project management experience
Understanding of CGMP/ISO standards, R&D, quality, engineering, and manufacturing
Knowledge of MS Office suite
Fluent level Korean; proficient in written and verbal English
About the Company:
Based in the United States, this international medical device company specialises in the development of innovative endovascular robotic systems.
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