Sr. Director, Quality Assurance and Regulatory Affairs @ (December 2021 - June 2024)
Associate Director, Regulatory Affairs @ (December 2016 - December 2021)
Director, Regulatory Affairs and Quality Systems @ Checkpoint Surgical, Inc (Previously with NDI Medical, LLC) (July 2013 - December 2016)
RAPS Webcast Speaker @ (July 2013 - July 2016)
Manager, Regulatory Affairs @ (September 2010 - July 2013)
Director, Operations, QA and RA @ American I.V. Products, Inc. (November 2008 - February 2010)
QA and RA Manager @ American I.V. Products, Inc. (May 2007 - November 2008)
QA and RA Coordinator @ (May 2004 - May 2007)
Robert Rogers Education
Oregon State University
Bachelors of Science (Biology, Psychology)
Northeastern University
Master of Science (M.S.) (Regulatory Affairs for Drugs, Biologics and Medical Devices)
Robert Rogers Skills
Regulatory Submissions
Iso 9000
Document Management
Quality Auditing
21 CFR
Trackwise
Quality Assurance
Recalls
Quality System
Operations Management
Change Management
Complaint Management
CE marking
ISO 13485
Computer System Validation
Auditing
21 CFR Part 11
Design Control
Validation
u.s. Food and Drug Administration Fda
CAPA
Six Sigma
Regulatory Affairs
cGMP practices
V&V
ISO
Regulatory
GMP
Leadership
Medical Device Directive
Technical Files
Cmdcas
FDA
Microsoft Office
ISO Standards
Medical Devices
ISO 14971
Regulatory Requirements
Sop
Change Control
Pharmaceutical Industry
GxP
FDA GMP
u.s. Food and Drug Administration
Robert Rogers Summary
Robert Rogers, based in Frederick, MD, US, is currently a Sr. Director, QA and RA at Oncocyte Corporation. Robert Rogers brings experience from previous roles at Digital Health Works, Hemanext, QIAGEN and Checkpoint Surgical, Inc (Previously with NDI Medical, LLC). Robert Rogers holds a Bachelors of Science in Biology, Psychology @ Oregon State University. With a robust skill set that includes Regulatory Submissions, Iso 9000, Document Management, Quality Auditing, 21 CFR and more. Robert Rogers has 3 emails and 2 mobile phone numbers on RocketReach.
Looking for a different Robert Rogers?
Find contact details for 700 million professionals.