Regulatory Affairs Specialist

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.