2002 -2008 Regulatory Consultant, Project Manager, Study Director @ Cook MED Institute
Deb Baker-Janis Education
Oregon Health & Science University
M.S. (Electrical and Computer Engineering)
2001-2002
University of Southern California
B.S. (Biomedical Engineering)
1996-2000
Deb Baker-Janis Skills
Regulatory Submissions
Global Regulatory Compliance
Design Control
Quality Auditing
Clinical Trials
Engineering
Project Management
Change Control
GMP
Validation
Medical Devices
Quality System
CAPA
CE marking
ISO 13485
V&V
FDA
Regulatory Affairs
ISO 14971
Sop
Development
Notification
Mesh
Clinical Research
Regulatory
Business Analysis
FMEA
Strategic Planning
Protocol
Testing
Change Management
Documentation
Research
Deb Baker-Janis Summary
Deb Baker-Janis, based in Grayslake, IL, US, is currently a Senior Regulatory Affairs Manager, North America at CooperVision. Deb Baker-Janis brings experience from previous roles at Network Partners, NSF - Health Sciences and Becker & Associates Consulting, Inc. and Becker Venture Services Group. Deb Baker-Janis holds a 2001 - 2002 M.S. in Electrical and Computer Engineering @ Oregon Health & Science University. With a robust skill set that includes Regulatory Submissions, Global Regulatory Compliance, Design Control, Quality Auditing, Clinical Trials and more. Deb Baker-Janis has 3 emails and 2 mobile phone numbers on RocketReach.
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