Tim Marjenin

Tim Marjenin has over 20 years of experience and expertise in the regulation of neurological devices and possesses extensive knowledge relating to the essential regulatory processes associated with neurological devices. His primary device and therapeutic expertise is in the areas of invasive and non-invasive neuromodulation for movement disorders, epilepsy, headache, Alzheimer’s Disease, headache, pain, and Psychiatric conditions. As Vice President, Head of Neurology Regulatory Affairs, Tim works closely with MCRA’s Regulatory department to support medical device developers and 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, preclinical, and clinical testing protocols, and summary documentation intended to support market clearance or approval. Before joining MCRA, Tim spent 16 years with the United States Food and Drug Administration. He served as a reviewer for nine years before moving on to Branch Chief in 2013. Tim served as a focal point for industry representatives and neuromodulation thought leaders and has represented FDA at numerous scientific conferences and symposia, and two meetings of the Neurological Devices Advisory Committee. He has received numerous individual and group awards for his regulatory work and leadership while at FDA.