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about 1 month ago
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Requirements and responsibilities
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 ResponsibilitiesLead 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 Requirements5–10+ 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
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