Regulatory Affairs @ Medtronic (retired) (January 2011 - July 2023)
Regulatory Affairs @ CSI (February 2008 - December 2010)
Regulatory Affairs @ (January 1999 - January 2008)
Department Manager, Orthopedic devices @ FlexMedics (January 1991 - January 1996)
David Brooke Education
Purdue University
BSME
1979-1983
David Brooke Skills
21 CFR
Biomedical Engineering
CAPA
CE marking
Clinical Trials
Commercialization
Cross-functional Team Leadership
DMAIC
Design Control
Design of Experiments
FDA
FMEA
GMP
ISO
ISO 13485
ISO 14971
Manufacturing
Medical Device Directive
Medical Devices
Minitab
PMA
Product Development
Program Management
Project Management
Quality Auditing
Quality System
R&D
Regulatory Affairs
Regulatory Requirements
Root Cause Analysis
SPC
Six Sigma
Supplier Quality
V&V
Validation
Strategic Planning
Cross Functional Team Leadership
Marketing
Pharmaceutical Industry
Microsoft Excel
David Brooke Summary
David Brooke, based in North Branch, MN, US, is currently a Regulatory Affairs Consultant at Independant. David Brooke brings experience from previous roles at Medtronic (retired), CSI, Boston Scientific and FlexMedics. David Brooke holds a 1979 - 1983 BSME @ Purdue University. With a robust skill set that includes 21 CFR, Biomedical Engineering, CAPA, CE marking, Clinical Trials and more. David Brooke has 1 mobile phone numbers on RocketReach.
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