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Staff Regulatory Affairs Lead - SaMD & AI Health Tech

United States Digital Space LLC

United States Digital Space LLC in Boston, MA is seeking a Staff Regulatory Affairs Associate to help shape regulatory strategy for SaMD, AI/ML-enabled devices, and wearable health tech. You will partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features and user experiences. Your work will involve regulatory interactions with FDA reviewers, notified bodies, and other authorities, and you will contribute to submissions like Q-Submissions, 510(k)s, and #J-18808-Ljbffr United States Digital Space LLC

Vacancy posted 2 days ago
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