Regulatory Expert, Digital Pathology
Ladders · United States · 2 days ago
RemoteRemoteHealthcare$124k–$233k/yrFull-time
Responsibilities
- Provide regulatory leadership for digital pathology products, ensuring global requirements are integrated early in development
- Define and execute global regulatory strategies and support submissions for FDA, EU IVDR, and international markets
- Lead meetings with regulatory bodies, including FDA
- Provide regulatory guidance on clinical validation, study design, and performance evidence
- Interpret and apply regulatory guidance for Software as a Medical Device (SaMD), AI/ML diagnostics, cybersecurity, and algorithm lifecycle
- Partner with R&D, clinical, quality, and commercial teams to enable compliant product development
- Identify regulatory risks and provide clear mitigation strategies and recommendations
Qualifications
- Bachelor's degree in scientific or engineering discipline; advanced degree preferred
- 8+ years of regulatory affairs experience in IVDs or medical devices
- Experience leading meetings with regulatory bodies on complex topics
- Promised background in digital pathology or software-based diagnostics
- Strong understanding of SaMD, AI/ML regulatory frameworks, and global regulatory requirements
Benefits
- Remote work option available
- Full-time weekly schedule
- Eligibility for bonus and stock options
- Comprehensive benefits package
- Flexibility in work location