Industry:
Medical Devices
Work:
Colorado Springs Chamber & Edc
Board Member
Philips
Head of Quality, Image Guided Therapy Devices
Spectranetics Jul 1, 2016 - Dec 2017
Vice President Quality Assurance
Spectranetics Sep 2014 - Jul 2016
Director, Regulatory Affairs
Fda Oct 2012 - Aug 2014
Senior Reviewer
Education:
Arizona State University
Bachelor of Science In Engineering, Bachelors, Biomedical Engineering
Skills:
Regulatory Affairs
Fda
Medical Devices
Biomedical Engineering
Iso 13485
Design Control
Capa
Quality System
Clinical Trials
Regulatory Submissions
Validation
Biotechnology
Design of Experiments
Regulatory Requirements
R&D
Technology Transfer
Clinical Development
Biomaterials
Gmp
Pma
Quality Assurance
V&V
Ce Marking
21 Cfr
Iso 14971
Sop
Gcp
Fda Gmp
Medical Imaging
Minitab
Lifesciences
Commercialization
Catheters
Medical Device Directive
Manufacturing
Glp
Biomechanics