John Doucet

Overview

John joined MCRA on August 31st, 2020 as Senior Director, Neurology Regulatory Affairs. At MCRA, John provides guidance on regulatory strategies and submissions development for MCRA’s neurology clients, as well as interacts on breakthrough device designation submissions and strategies across various therapies. 

Tim Marjenin

Overview
 

As Vice President, Neurology Regulatory Affairs, Mr. Marjenin works closely with MCRA’s Regulatory department to support medical device manufacturers as they work to develop submissions to FDA at every stage, from early concept to marketing applications. The includes the development of regulatory strategy, non-clinical, pre-clinical, and clinical testing protocols, and summary documentation intended to support market clearance or approval.

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