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Sean Amato is a Senior Consultant at Devote Consulting, contributing to SaMD development through systems engineering, document authoring, and regulatory strategy since May 2023. Notably, Sean authored a Software as a Medical Device Design History File (DHF) for an EU submission that achieved market authorization under the EU MDR. Prior experience includes a role as Senior Regulatory Affairs Associate at Amgen from August 2016 to April 2023, where Sean supported regulatory submission activities for medical devices, along with earlier positions as Manufacturing Associate and Associate Engineer. Sean holds a Bachelor's degree in Chemical Engineering from Oregon State University and is currently pursuing a Master's degree in Data Science at CUNY School of Professional Studies from August 2023 to June 2027.