Regulatory Affairs Specialist
About The Position
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
- 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.
- Bachelor’s degree in science, engineering, or related field (advanced degree preferred).
Nice To Haves
- Experience with oncology diagnostics or multi-omic assays.
- Familiarity with CLIA/CAP laboratory environments.
- Experience with Breakthrough Device Designation submissions.
- RAC certification preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
