Jungju Kohm
- Role
- Sr Clinical Product Risk Specialist at Boston Scientific
- Location
- Tampa, FL, US
- LinkedIn followers
- 500 followers
About Jungju Kohm
Clinical pharmacist with a strong background in oncology/immunology and ten years of…
Experience
Sr Clinical Product Risk Specialist
Jan 2022 — Present
Author CER/CEP/PMCF-ER/PMCF-P/SSCPs in compliance with EU MDR and MDCG/MEDDEV 2.7/1 Rev. 4 guidelines. • Conduct systematic literature reviews and data analysis to author comprehensive analytical clinical evaluation reports for diverse medical devices. • Assist in writing and preparation of regulatory submissions and regulatory responses from various regulatory authorities and organizations (FDA, Health Canada, PMDA, ANVISA, and Notified Bodies) to ensure timely and accurate…
Education
University of Illinois Chicago
Doctor of Pharmacy (PharmD), Pharmacy
2012 — 2017
University of Hawaii Maui College
Registered Nursing/Registered Nurse
2002 — 2004
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