Senior Director of Regulatory Compliance @ (March 2014 - October 2015)
Senior Notified Body Project Manager @ DEKRA Certification (formerly KEMA Medical) (March 2005 - March 2014)
Director, Research and Development @ Oculus Innovative Sciences (March 2004 - March 2005)
Manager, IVUS Disposable Development; Senior Scientist, IVUS Transducer Development @ Jomed Inc./Volcano Therapeutics, CA, USA & Jomed Imaging Limited, UK (June 2000 - March 2004)
Doctoral Research Associate @ Laboratoire d'Aérothermique (CNRS) (November 1999 - March 2000)
PhD Student @ UKAEA, Culham (January 1995 - January 1999)
Keith Morel Education
Imperial College London
PhD (Plasma Physics (Nuclear Fusion))
1995-1999
Imperial College London
BSc (Physics)
1992-1995
UCSF Extension
Keith Morel Skills
21 CFR Part 11
510(k)
Audit Reports
Auditing
Biomedical Engineering
CAPA
CE marking
Cardiovascular Devices
Class III Medical Devices
Clinical Evaluation
Clinical Evaluation for Medical Devices
Clinical Trials
Combination Devices (drug-device combinations)
Corrective Actions
Corrective and Preventive Action (CAPA)
Critical Thinking
DMAIC
Data Analysis
Decision-Making
Design Control
Design Dossiers
Design of Experiments
Drug Eluting Stents
EU MDR
FMEA
GMP
Global Regulatory Compliance
ISO
ISO 13485
ISO 14971
ISO Standards
Internal Audits
International Regulations
Interpreting Data
Interventional Cardiology
Leadership
MDSAP
Management
Management Systems
Manufacturing
Medical Device Directive
Medical Device Regulation (MDR)
Medical Devices
Negotiation
Peripheral Vascular
Physics
Plasma Physics
Premarket Approval (PMA)
Presentations
Process Capability
Process Engineering
Process Simulation
Product Development
Project Management
Quality Assurance
Quality Auditing
Quality Control
Quality Engineering
Quality Management
Quality System
Quality Systems
R&D
Regulatory Affairs
Regulatory Approvals
Regulatory Compliance
Regulatory Guidelines
Regulatory Requirements
Regulatory Strategy
Regulatory Submissions
Research and Development (R&D)
Risk Management
Risk Management for Medical Devices
Root Cause
Statistical Data Analysis
Statistical methods
Stents
Testing
Training
U.S. Food and Drug Administration (FDA)
V&V
Validation
Vascular Surgery
Verification and Validation (V&V)
Verification and Validation V&V
Corrective and Preventive Action Capa
Research and Development R&d
Combination Devices Drug Device Combinations
Verification and Validation
Corrective and Preventive Action
Research and Development
Combination Devices
Keith Morel Summary
Keith Morel, based in Los Angeles, CA, US, is currently a VP of Regulatory Compliance and Medical Device Business Unit Lead at Qserve Group US Inc.. Keith Morel brings experience from previous roles at USC School of Pharmacy and Accuray. Keith Morel holds a 1995 - 1999 PhD in Plasma Physics (Nuclear Fusion) @ Imperial College London. With a robust skill set that includes 21 CFR Part 11, 510(k), Audit Reports, Auditing, Biomedical Engineering and more. Keith Morel has 5 emails and 4 mobile phone numbers on RocketReach.
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