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 she served as Director of Regulatory Affairs.  Maureen was at Dade Behring for 15 years and has also worked at Diamics and Abbott Laboratories.

Maureen has deep experience in many phases of regulated product development and marketing.  She has played leadership and execution roles in approval/clearance projects, product development, quality system development, clinical trials and post-market compliance. 

In addition to obtaining numerous FDA approvals and clearances, Maureen has had approvals in Canada, EU, China and Japan.

Maureen earned a BS in Environmental Science from Aurora University and has been Regulatory Affairs Certified since 1999.  She earned her MBA at Golden Gate University in 2003.

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Glossary Terms

In Vitro Diagnostic (IVD)
Quality
Quality System