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Regulatory Manager-US at Symmetrio. Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.   . Key Responsibilities . Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products . Develop and execute regulatory strategies supporting product development and commercialization . Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance . Interpret FDA guidance related to medical device software and digital health technologies . Partner with global regulatory teams to support international regulatory initiatives . 5–10+ years of regulatory affairs experience in medical devices or healthcare software . Proven experience with FDA 510(k) submissions, ideally for software-based medical devices . Strong knowledge of SaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304) . Experience working within a multinational organization . Strong cross-functional collaboration and communication skills . Company Location: United States.