To ensure regulatory compliance of Software as a Medical Device (SaMD) products across US and international markets, the full-time hybrid FDA Regulatory Specialist will manage FDA submissions, support global regulatory strategy, and maintain quality management systems. Key Responsibilities Prepare and manage FDA submissions, including 510(k) and DeNovo pathways, ensuring completeness and compliance of all regulatory documentation Support development of US reimbursement strategies and ensure compliance with FDA, SOC2, and MDSAP requirements Maintain and improve Quality Management System (QMS) processes related to regulatory compliance and support audits Required Qualifications Bachelor's or Master's degree in Life Sciences, Engineering, Regulatory Affairs, or related field 7+ years of experience in regulatory affairs with a focus on FDA submissions Experience with SaMD, ISO 13485, ISO 14971, and MDR compliance Knowledge of clinical studies and understanding of the US reimbursement landscape is a plus Experience with SOC2 / MDSAP is a plus