Regulatory Expert, Digital Pathology Job at Agilent, Indiana

  • Agilent
  • Indiana

Job Description

Responsibilities

  • Provide regulatory leadership for digital pathology products including whole slide imaging and image analysis algorithms
  • Define and execute global regulatory strategies and support submissions to FDA, EU IVDR, and international markets
  • Lead meetings with regulatory bodies and translate complex regulatory expectations into practical strategies
  • Provide guidance on clinical validation, study design, and performance evidence requirements for digital pathology
  • Partner with R&D, clinical, quality, and commercial teams to enable compliant product development

Requirements

  • Bachelor's degree in scientific or engineering discipline; advanced degree preferred
  • 8+ years regulatory affairs experience in IVDs or medical devices
  • Demonstrated experience leading meetings with regulatory bodies on complex topics
  • Expertise in digital pathology or software-based diagnostics
  • Strong understanding of SaMD, AI/ML regulatory frameworks, and global requirements

Compensation: $124,160-$232,800 base plus bonus, stock, and benefits

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