Regulatory Expert, Digital Pathology
$124,160–$232,800 year
Remote · United States or Carpinteria, California, United States
Job Summary
Regulatory Expert for Digital Pathology, responsible for providing strategic and tactical regulatory leadership across digital pathology products (including whole slide imaging, image analysis algorithms, and integrated workflows). Lead global regulatory strategies, prepare submissions (FDA and EU IVDR), advise on clinical validation and performance evidence, and guide R&D/QA/commercial teams to ensure compliant product development and lifecycle management. Requires deep knowledge of SaMD, AI/ML regulatory considerations, cybersecurity, and cross-functional collaboration to integrate regulatory expectations throughout development and post-market activities.
Required 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
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