Amaris leads the Quality Assurance and Regulatory Affairs team at Simbex, providing regulatory compliance and quality product development oversight including regulatory strategy, usability, risk analysis, verification & validation activities, auditing, and continuous process improvements. Amaris has worked in the medical device and consumer health product development field with deep vertical market experience covering pain management, electrical stimulation, wound healing/prevention, and rehabilitation and assistive technologies. Amaris is a strong believer in user-centric design that delivers safe and effective therapies.
Amaris holds a doctorate in Biomedical Engineering from the University of Miami and a B.S. in Biomedical Engineering from Tulane University, specializing in orthopedic research. She holds a Regulatory Affairs Credential (RAC) in Medical Devices.
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