Mya Thomae, RAC, CQA
Founder and CEO
Mya has almost 20 years of experience with regulatory and quality, much of it as a consultant. Prior to becoming a consultant, Mya learned the ropes at Chiron and OraSure....
Consultants
Leonard Buchner
Senior Director
Leonard has more than 30 years of experience in the IVD industry and posseses industry-leading expertise applying biostatistics to analytic studies and clinical trial design. Leonard has extensive experience building,...
Cathy Craft, RAC
Senior Director
Cathy has more than 30 years of experience in the medical world. She has worked for Dade Behring and Siemens Healthcare Diagnostics, as the Director of Regulatory Affairs/Labeling and VP...
Barbara Elashoff, MS
Director
Barbara has more than 15 years of experience as a biostatistician, including five years as a statistical reviewer at FDA. Barbara comes to Myraqa from a ten-year career as an...
Jo-Ann Gonzales, RAC
Associate Director
Jo-Ann has over 12 years of regulatory experience, 10 of which have been specifically with IVDs. She comes to Myraqa having served in regulatory for four years at Novartis and...
Steve Gutman, MD
Strategic Advisor
Steve has more than 30 years of medical industry experience with 15+ years at FDA, where he founded and directed OIVD, the Office of In Vitro Diagnostics. Steve holds a...
Lorry Huffman, RAC, MBA, MT
Senior Director
Lorry has more than 20 years of experience managing regulatory affairs in both the device and pharma industries. Lorry has built and supervised RA/QA departments and led regulatory efforts in...
David Kern, RAC, MBA
Senior Director
Dave has more than 20 years of experience developing IVD and life science products. His experience in product development, project management, business development and relationship management grants him a wide...
Claudia Koontz
Clinical Research Associate
Claudia has a diverse array of experiences supervising projects, resources, communications and accounting functions in a variety of industries. Over 15+ years, Claudia has played key roles in clinical, telecommunications,...
Tina M. Landess, CCRA
Director
Tina has more than 12 years of experience with clinical trials as both a consultant and permanent employee of Roche Molecular Systems, BioMedicines, Bayer Diagnostics, Chiron and most recently, Vermillion....
Maureen Mende, RAC, MBA
Senior Director
Maureen has over 25 years of experience in the regulatory and quality arenas, including 16 years specifically in IVD regulatory. She comes to Myraqa from two years at Affymetrix, where...
Deb Morris
Senior Director
Deb has more than 30 years of medical industry experience, primarily specializing in Regulatory and Clinical Affairs. Her expertise includes product development and strategy building. Deb comes from GE Healthcare...
Ann Rea, PMP
Director of Project Management
Ann has more than 10 years of project management experience in the technology and life science industries, with a particular focus on developing, supporting, implementing and managing software projects. Ann...
Gene Redig, CQA, CSQE, CQM
Senior Director
Gene has more than 25 years of experience in many facets of R&D, quality and regulatory. He has spent most of the last ten years working specifically in medical devices...
Nancy Schatz
Director
Nancy has years of experience as a statistician in the medical world, working for the Home Diagnostics Division of Nipro Diagnostics, MDVIP, Battelle CRO and most recently, CSL Plasma Limited....
Mark M. Sweeny, MA
Affiliate
Mark Sweeny was a key player in the regulatory, quality and compliance function at Applied Biosystems from 1990 until he joined Myraqa in 2008. During his time at AB, Mark...
Phil Tayco
Clinical Database Manager
Phil has more than 15 years of experience working in the information technology and project management field. He has past work history in clinical data as a Database Manager and...
Cindy Van Duker, RAC
Director
Cindy has more than 10 years of experience managing regulatory affairs for IVD and medical device products. She comes to Myraqa from Volcano Corporation, where she served as Manager of...
Diane M. Ward, PhD
Senior Director
Diane Ward is an immunologist with over 20 years of experience in the diagnostic industy and has a comprehensive track record in new product development. With particular expertise in systems...
Jack Ward, CQM, CSQE
Senior Director
Jack Ward has more than 25 years of experience working with quality, compliance and R&D at a wide range of medical device companies. Jack spent more than 10 years in...
Operations
Keith Buchner
Marketing Specialist
Keith joined Myraqa after finishing his undergraduate work. He is motivated to use his marketing background in the life science industry. Keith has been involved in building various marketing campaigns,...
Bryan Hardester
Finance Manager
Bryan is an accomplished musician who became a top performer at his "day job" by bringing an artistic level of discipline and dedication to everything he does. Bryan has managed...
Dave Moore
Director of Fun
Dave Moore comes to Myraqa from Adobe Systems, where he was a Volume Licensing Manager. Dave has had management positions in software, marketing, retail and nonprofits. Although he is new...
