With 20 plus years of demonstrated hands-on experience navigating the global regulatory landscape (US, Europe, Asia and Australia), Randall has successfully assisted organizations achieve market authorization by developing efficient quality management systems, managing human clinical trials, preparing technical files, and coordinating regulatory submissions.
From 2009 through March 2017, Randall served as a Principal Consultant to the Brien Holden Vision Institute (Sydney, Australia) and as Vice President, Quality & Regulatory Affairs for the commercial entities of the Brien Holden Vision Institute including Brien Holden Vision Pty Ltd (Sydney, New South Wales, Australia) and Brien Holden Vision Diagnostics, Inc., (Ontario, California, USA).
In addition to participating in various medical device start-ups in the United States, Randall has participated in the start-up of ophthalmic medical device companies in Australia, China, Turkey, Switzerland, and Vietnam.
Randall maintains active memberships in the Regulatory Affairs Professional Society (RAPS), American Association of Medical Instrumentation (AAMI) and Society of Clinical Research Associates (SoCRA).
Randall holds degrees in both Business Administration and Mathematics and has completed undergraduate work at California State Polytechnic University, Pomona, California, USA leading to a Bachelor of Science in Mechanical Engineering.
Randall is certified by General Electric as a Six Sigma Quality Blackbelt and has led numerous Six Sigma Quality Initiatives.
Randall has demonstrated competency and is certified by Exemplar Global as an ISO 13485:2016 Lead Auditor.
Randall currently resides in Yorba Linda, California.
Contact Randall May
President and Principal Consultant
Randall May & Associates, Inc.
650 North Rose Drive, Suite 330,
Placentia, California 92870 USA
p: +1 949 209 8769
c: +1 714 612 1870
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