Mr. Marjenin has over 16 years of experience and expertise in the regulation of neurological devices. He possesses extensive knowledge and experience related to the regulatory processes associated with neurological devices. While 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, he also has experience with neurodiagnostic and neurointerventional devices.
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.
Mr. Marjenin holds a bachelor’s degree in biomedical engineering from Case Western Reserve University in Cleveland, OH.
Before rejoining MCRA in August 2020, Mr. Marjenin spent 16 years with the United States Food and Drug Administration. He served as a reviewer for nine years before being selected as a Branch Chief in 2013. His focus as both a reviewer and a manager has been neurological devices using a variety of technologies for a number of different intended uses. As Branch Chief, Mr. Marjenin reviewed and edited scientific memoranda from a multi-disciplinary team of scientists, engineers, and clinicians, with branch-level signatory authority over all regulatory decisions on De Novo, PMA, IDE, and 510(k) medical device submissions pertaining to invasive and non-invasive neuromodulation devices.
Many of the devices that were under Mr. Marjenin’s regulatory purview represent important therapeutic options in the treatment of neurological and psychiatric conditions, affecting millions of patients in the United States. Mr. Marjenin served as a focal point for industry representatives and neuromodulation thought leaders, and has represented FDA at numerous scientific conferences and symposia, and before two meetings of the Neurological Devices Advisory Committee. He received numerous individual and group awards for his regulatory work and leadership.
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.