We are seeking an experienced Regulatory Affairs Expert in digital pathology to provide strategic and tactical regulatory leadership for digital pathology products, including software, image analysis algorithms, and integrated diagnostic systems.
This role serves as a key regulatory partner to R&D, Clinical, Quality, and Commercial teams, ensuring regulatory requirements for digital pathology solutions are proactively integrated throughout the product lifecycle, from development through commercialization and post-market activities.
The Regulatory Expert will act as a subject matter expert in digital pathology, with deep understanding of global regulatory frameworks (e.g., FDA, EU IVDR/MDR), software-driven diagnostics, and companion diagnostic applications. This role translates complex regulatory expectations into clear, practical strategies.
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
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.
Additional Details
This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least June 17, 2026 or until the job is no longer posted.Job details are sourced from the employer's original posting.
Open job postingAbout the company
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek.-- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.