Job Description
Description:
JOB PURPOSE:
· 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.
ESSENTIAL RESPONSIBILITIES:
· 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.
Requirements:EXPERIENCE & QUALIFICATIONS:
· 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.
Preferred Qualifications
· Experience with oncology diagnostics or multi-omic assays.
· Familiarity with CLIA/CAP laboratory environments.
· Experience with Breakthrough Device Designation submissions.
· RAC certification preferred.
EDUCATION:
· Bachelor’s degree in science, engineering, or related field (advanced degree preferred).
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