Valerie Merkle, PhD

Associate Director, Regulatory Strategy

Valerie Merkle, PhD, who brings extensive knowledge of medical device regulations and regulatory strategy to Syntactx, provides expert assistance to clients seeking product approvals and adoption worldwide.

Dr. Merkle led a remarkably successful career with the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH) as a Lead Reviewer for vascular and endovascular surgical devices. In her role, she managed and reviewed over 650 complex regulatory submissions, including pre-submissions, investigational device exemptions, as well as 510(k) and PMA marketing submissions. She was the lead reviewer for First of a Kind vascular devices and served as the FDA lead to the meeting of the Circulatory System Devices Panel. Her additional expertise and outreach include standards work, cardiovascular materials research, and FDA/external research collaborations. She is also a frequent lecturer at colleges and universities on regulatory and biomedical engineering topics. Valerie is a Steering Committee Member for the Greenberg Stent Summit, a unique conference that brings together representatives from industry, clinical practice, and FDA to discuss current issues in endovascular interventional therapy.

Valerie holds a Bachelor of Science in Chemical Engineering from Bucknell University, a PhD in Biomedical Engineering from the University of Arizona, and is an Innovation Fellow of the Fogarty Institute. She has co-authored numerous peer-reviewed manuscripts and has presented at multiple academic, scientific, and technical conferences. She is the recipient of FDA honors including the 2019 CDRH Excellence in Premarket Review Team Award for which she was the lead reviewer and the 2017 FDA Outstanding Service Award.

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