Providing scientific and regulatory support, the full-time Biomedical Engineer Subject Matter Expert will evaluate medical devices, manage regulatory submissions, and coordinate with FDA stakeholders while working remotely. Key responsibilities Perform technical and regulatory reviews of medical devices to assess design, intended use, and performance data Evaluate scientific and engineering information submitted for various regulatory pathways, including 510(k) notifications and De Novo requests Analyze complex engineering issues to support regulatory recommendations and ensure consistent application of standards across teams Required qualifications Bachelor's degree in Engineering, Biomedical Engineering, or a closely related discipline Minimum of seven years of professional experience in engineering, medical devices, or regulatory affairs Demonstrated knowledge of medical device technologies and FDA regulatory frameworks Strong analytical and technical writing skills for clear communication of complex concepts Proficiency in Microsoft Office Suite applications
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