About this role

Provide regulatory leadership for digital pathology products, including whole slide imaging systems, image analysis algorithms, and integrated workflows
Ensure global regulatory requirements are incorporated early in development
Define and execute global regulatory strategies and support submissions (FDA, EU IVDR, and international markets)
Lead meetings with regulatory bodies, including FDA
Provide regulatory guidance on clinical validation, study design, and performance evidence requirements for digital pathology
Interpret and apply regulatory guidance for Software as a Medical Device (SaMD), AI/ML diagnostics, cybersecurity, and algorithm lifecycle management
Partner with R&D, clinical, quality, and commercial teams to enable compliant product development and execution
Identify regulatory risks and provide clear mitigation strategies and recommendations to leadership

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

Regulatory Expert, Digital Pathology

Key skills