Regulatory Affairs Specialist

About This Role

This role involves executing the regulatory strategy for AI/ML-based Software as a Medical Device (SaMD) products, including AidaBreast, with a focus on novel oncology diagnostic technologies. The specialist will ensure alignment with FDA expectations and collaborate cross-functionally to develop clinically impactful breast cancer risk assessment tools.

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.

Nice to have:

• Experience with oncology diagnostics or multi-omic assays.

• Familiarity with CLIA/CAP laboratory environments.

• Experience with Breakthrough Device Designation submissions.

• RAC certification preferred.

• Bachelor

Benefits

• Advanced degree preferred.

About the Company

PreludeDx is an innovative healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from the University of California San Francisco, PreludeDx focuses on developing precision breast cancer tools that impact a patient's treatment decision. Its mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system.