Regulatory Affairs Specialist

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Regulatory Affairs Specialist

• Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including Aida Breast.
• 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.

• 6+ years regulatory experience in medical devices or digital health.
• Direct experience leading De Novo submissions (required).
• Experience with SaMD and AI/ML-based algorithms strongly preferred.
• Strong knowledge of FDA regulatory frameworks and guidance for SaMD.
• Experience with clinical validation of diagnostic or predictive models.

• Experience with oncology diagnostics or multi-omic assays.
• Familiarity with CLIA/CAP laboratory environments.
• Experience with Breakthrough Device Designation submissions.

• Bachelor's degree in science, engineering, or related field (advanced degree preferred).