Regulatory Expert, Digital Pathology
Core
Provide strategic and tactical regulatory leadership for digital pathology products, including software, image analysis algorithms, and integrated diagnostic systems.
Role type
Senior Regulatory Affairs Expert (Digital Pathology/SaMD)
Builds
Digital pathology solutions, whole slide imaging systems, and image analysis algorithms
Domain
Medical Devices / Digital Pathology / Software as a Medical Device (SaMD)
Deliverable
client delivery
Required skills
Global regulatory frameworks (FDA, EU IVDR/MDR), Software as a Medical Device (SaMD), AI/ML diagnostics, algorithm lifecycle management, clinical validation study design, regulatory risk mitigation
Preferred skills
Advanced degree in scientific or engineering discipline
Technologies
Whole slide imaging systems, image analysis algorithms
Responsibilities
Define and execute global regulatory strategies and support submissions (FDA, EU IVDR), Lead meetings with regulatory bodies, Provide regulatory guidance on clinical validation and performance evidence, Partner with R&D, clinical, quality, and commercial teams, Identify regulatory risks and provide mitigation strategies
Seniority
Senior, hands-on IC