Director, Quality Affairs @ Diagnostic Hybrids, Inc. (July 2010 - June 2020)
Staff Clinical Research Scientist and Study Manager @ (March 1988 - December 2005)
Karl Luke Education
Madison University, Gulfport, MS
Doctor of Philosophy (Ph.D.) (Health Care Considerations Used in the Development of In Vitro Diagnostic Test Systems)
2001-2002
Karl Luke Skills
Biotechnology
Clinical Research
Design Control
FDA
ISO 13485
Medical Devices
PCR
Quality System
Regulatory Affairs
Regulatory Submissions
Microsoft Excel
Regulatory
Microsoft Word
Molecular Biology
Leadership
Karl Luke Summary
Karl Luke, based in Athens, OH, US, is currently a Sr. Director, Clinical and Regulatory Affairs at Quidel. Karl Luke brings experience from previous roles at Quidel and Diagnostic Hybrids, Inc.. Karl Luke holds a 2001 - 2002 Doctor of Philosophy (Ph.D.) in Health Care Considerations Used in the Development of In Vitro Diagnostic Test Systems @ Madison University, Gulfport, MS. With a robust skill set that includes Biotechnology, Clinical Research, Design Control, FDA, ISO 13485 and more. Karl Luke has 2 emails on RocketReach.
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