Senior Consultant
Heesang YOO
Life Sciences · Pharmaceuticals
Expertise
Recently reviewed Professionals
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.
Education
| 2008 | Dankook University - Ph.D. in Applied Optics |
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| 1997 | Konkuk University - M.A. in Management Information Systems |
| 1985 | Korea University - A.S. in Radiologic Science |
Work Experience
| 2020-Present | Lee & Ko |
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| 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 |
Languages
| Korean |
Awards and Recognitions
| 2015 | Korea Official Award President |
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| 2008 | Exemplary Official Award Prime minister |
