Regulatory Affairs Specialist

Prelude Corporation

FULL_TIME

Salary

$0 - $0 per yearly

Location(s)

  • Laguna Hills CA US

Description

· 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 requiremen

Tags

  • Healthcare

How to apply

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