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.

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:

Bachelors degree in science engineering or related field (advanced degree preferred).