Regulatory Expert, Digital Pathology

Agilent · Carpinteria, CA +1 more

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RegulatoryRemoteFull-time$124k–$233kCompany career page

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What they're looking for

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

What you'll be doing

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

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Date posted8 days ago

Last source check1 day ago

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