2013 -2016 Director, Regulatory Affairs and Quality Systems @ Checkpoint Surgical, Inc (Previously with NDI Medical, LLC)
2013 -2016 RAPS Webcast Speaker @
2010 -2013 Manager, Regulatory Affairs @
2008 -2010 Director, Operations, QA and RA @ American I.V. Products, Inc.
2007 -2008 QA and RA Manager @ American I.V. Products, Inc.
2004 -2007 QA and RA Coordinator @
Robert Rogers Education
Oregon State University
Northeastern University
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 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.
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