Director Clinical Operations @ (September 2023 - October 2025)
Associate Director Of Clinical Operations and Regulatory Affairs @ (January 2022 - September 2023)
Sr. Manager, Clinical and Regulatory Affairs @ (July 2019 - December 2021)
Director Clinical Affairs @ ROX Medical (December 2018 - June 2019)
Sr. Manager Clinical Affairs @ (April 2018 - December 2018)
Sr. Clinical Affairs Manager @ ROX Medical (August 2007 - April 2018)
Director of Finance and Business Operations @ AcuFocus, Inc. (August 2003 - August 2007)
Associate and CSO @ (August 1999 - August 2003)
Helen Lee Education
UC San Diego
BS
UC San Diego
Minor
UC Irvine
Certificate Program
Helen Lee Skills
21 CFR Part 11
Biomedical Engineering
Biotechnology
CAPA
CRO
CTMS
Capital Equipment
Cardiology
Clinical Data Management
Clinical Development
Clinical Monitoring
Clinical Research
Clinical Trials
Commercialization
Design Control
Design of Experiments
EDC
Electrophysiology
FDA
GCP
GMP
Healthcare
ICH-GCP
ISO 13485
ISO 14971
Infectious Diseases
Interventional Cardiology
Interventional Radiology
Lifesciences
Medical Devices
Medical Imaging
Neurology
Oncology
Ophthalmology
Pharmaceutical Industry
Product Launch
Protocol
Quality Assurance
Quality System
R&D
Regulatory Affairs
Regulatory Submissions
Sop
Start-ups
Surgery
Technology Transfer
Therapeutic Areas
V&V
Validation
Vascular
Clinical Affairs
Interventional
Business Analysis
Ich Gcp
Finance
Start Ups
Project Management
Helen Lee Summary
Helen Lee, based in United States, is currently a Sr. Director of Clinical Operations at VS3 Medical. Helen Lee brings experience from previous roles at Self-employed and Neuros Medical, Inc.. Helen Lee holds a BS @ UC San Diego. With a robust skill set that includes 21 CFR Part 11, Biomedical Engineering, Biotechnology, CAPA, CRO and more. Helen Lee has 1 emails and 3 mobile phone numbers on RocketReach.
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