Regulatory Expert, Digital Pathology
About The Position
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.
Requirements
- 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.
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
Benefits
- bonus
- stock
- benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
