Director, Clinical and Regulatory Affairs @ (January 2013 - Present)
Director, International Regulatory Compliance @ Diagnostic Hybrids, Inc. (January 2006 - Present)
Director, Quality Affairs @ Diagnostic Hybrids, Inc. -- A Quidel Company (January 2006 - Present)
Director, Quality Affairs @ Diagnostic Hybrids, Inc., A Quidel Company (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
FDA
Medical Devices
Biotechnology
Regulatory Submissions
Clinical Research
ISO 13485
Quality System
Design Control
Regulatory Affairs
PCR
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, Quidel Corporation (and its wholly owned subsidiary Diagnostic Hybrids, Inc.), Diagnostic Hybrids, Inc. and Diagnostic Hybrids, Inc. -- A Quidel Company. 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 FDA, Medical Devices, Biotechnology, Regulatory Submissions, Clinical Research and more. Karl Luke has 2 emails on RocketReach.
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