2011 -
2014 Director of Regulatory Affairs @ Cybersonics Inc.
1989 -
2011 Manager, Regulatory Affairs @
Lori Colvin Education
Gannon University
Lori Colvin Skills
Regulatory Affairs
ISO 14971
Regulatory Strategy
Regulatory Submissions
Design Control
510 K
FDA
Medical Devices
Quality Systems
CE marking
QSR
Regulatory Requirements
Quality Assurance
EU
Quality Auditing
ISO 13485
CAPA
Quality System
Medical Device Directive
European Union
Regulations
21 CFR
FDA GMP
ISO
Software Documentation
V&V
21 CFR Part 11
Technical Files
PMA
Sop
Combination Products
Strategy
Standard Operating Procedure (SOP)
Public Speaking
Sales
Regulatory
Microsoft Office
Marketing
Project Management
Standard Operating Procedure Sop
Pharmaceutical Industry
Standard Operating Procedure
Lori Colvin Summary
Lori Colvin, based in Erie, PA, US, is currently a Director of Quality and Regulatory at Industrial Sales and Manufacturing Inc.. Lori Colvin brings experience from previous roles at Cybersonics Inc. and STERIS Corporation. Lori Colvin holds a Gannon University. With a robust skill set that includes Regulatory Affairs, ISO 14971, Regulatory Strategy, Regulatory Submissions, Design Control and more. Lori Colvin has 2 emails and 1 mobile phone numbers on RocketReach.
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