Regulatory Affairs Specialist

Regulatory Strategy Lead For AI/ML-Based SaMD Product Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic biomarkers. Ensure alignment with FDA expectations for Breakthrough Device Designation (BDD), SaMD, and clinical validation requirements. Collaborate cross-functionally to support development of clinically impactful breast cancer risk assessment tools. Develop and execute regulatory strategies for De Novo and Breakthrough Device submissions. Author and compile high-quality FDA submissions including device description, intended use, software documentation, and clinical evidence. Lead FDA interactions including Q-Submissions, Pre-Subs, and deficiency responses. Translate complex AI/ML algorithms and biomarker data into clear regulatory documentation. Collaborate with Clinical, Biostatistics, Data Science, and Software teams on validation strategies. Ensure alignment with QMS and regulatory standards (IEC 62304, ISO 14971).Support regulatory positioning of prognostic and predictive oncology claims.