Regulatory Expert, Digital Pathology

$124.16k - $232.8k

Agilent

Indiana

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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Vacancy posted 24 days ago

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