Regulatory Expert, Digital Pathology

Key Responsibilities

• 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.

Qualifications

• 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.