Senior Consultant
Heesang YOO
Life Sciences · Pharmaceuticals
Heesang Yoo is a senior regulatory expert in the Korean medical device field. Having worked at the Ministry of Food and Drug Safety, Mr. Yoo brings with him 20 years of experience in the medical device total product lifecycle.
He has held various scientific and leadership positions at Ministry of Food and Drug Safety and has contributed in developing medical device safety policy, securing premarket safety, quality management system as well as post-market surveillance.
He has held various scientific and leadership positions at Ministry of Food and Drug Safety and has contributed in developing medical device safety policy, securing premarket safety, quality management system as well as post-market surveillance.
학력
| 2008 | Dankook University - Ph.D. in Applied Optics |
|---|---|
| 1997 | Konkuk University - M.A. in Management Information Systems |
| 1985 | Korea University - A.S. in Radiologic Science |
경력
| 2020-Present | Lee & Ko |
|---|---|
| 2022-Present | Consultant, Medical Device Consulting Council (MDCC) of KHIDI |
| 2021-Present | Consultant, Medical Device Industry Promotion Foundation |
| 2021-Present | Consultant, Korea Medical Device Distribution Association |
| 2021-Present | Chairman, Korea Medical Devices Association, Medical Device Advertising Autonomous Deliberation Committee |
| 2020-Present | Adjunct Professor, Medical Device Engineering and Management Dept.,Yonsei University |
| 2021-2024 | Commissioner, Medical Devices Committee, Ministry of Food and Drug Safety |
| 2021-2022 | Commissioner, Medical Device Industry medium-and long-term Strategy Planning, Korea Health Industry Development Institute |
| 2021-2022 | Consultant, Korea Medical Devices Industry Association |
| 2020-2020 | Director, Medical Device Management Division, Team for COVID-19, Ministry of Food and Drug Safety |
| 2017-2019 | Director, Medical Device Safety Evaluation Division, Regulatory Innovation TF, Ministry of Food and Drug Safety |
| 2015-2016 | Director, Approval &Review Team in Reorganization of Standards and Review System TF, Ministry of Food and Drug Safety |
| 2013-2015 | Adjunct Professor, Medical Device Dept, Graduate School of Dongguk University |
| 2008-2012 | Deputy Director, Medical Device Management Division, Diagnostic Medical Device Division, Medical Device Policy Division, Food and Drug Safety Administration |
| 2008-2009 | Exam Questions Committee, state examination of Medical Engineer |
| 2008-2008 | Leader, Medical Device TF Team, Seoul Regional Food and Drug Administration |
| 2005-2006 | Commissioner, Medical Material Division Dept, Health and Medical Information Standardization Committee of the Ministry of Health and Welfare |
| 2000-2007 | Assistant Director, Medical Devices Division, Medical Device Safety Division, Medical Device Safety Policy Division, Korea Food and Drug Administration |
언어
| Korean |
관련소식
최근업무사례
글로벌 의료기기 회사의 국내 이식용 의료기기 업체 인수 관련 자문 2024.04.03최근업무사례
글로벌 뷰티여성용품 회사를 위하여, 약사법 표시광고 검토 및 식약처 우호적 유권해석 도출 2024.01.31언론보도
[머니투데이] 식품·바이오 전문가 뜬다...광장 '헬스케어 형사팀' 신설 2023.02.27언론보도
[헤럴드경제] "디지털헬스 성장 가속...상용화까지 원스톱 솔루션 제공" 2023.01.03언론보도
[중앙일보] "헬스케어기업에 법률 이슈 터지면, 가장 먼저 찾는 곳" - 헬스케어팀 2022.02.25언론보도
[파이낸셜뉴스] 제약·바이오 분야 공 들이는 로펌들... 인재 영입 경쟁 뜨겁다 2020.11.22