Regulatory Expert, Digital Pathology
Agilent Technologies, Carpinteria, CA, Remote
Regulatory Affairs ComplianceBachelor RequiredSenior
About the role
Job Description
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, withdeepunderstanding 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
- Provideregulatory 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
- Identifyregulatory risks and provide clear mitigation strategies and recommendations to leadership
Qualifications
- Bachelor’s degree inscientificor 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.
Travel Required:
Occasional
Shift:
Day
Duration:
No End Date
Job Function:
Quality/Regulatory
About Agilent Technologies
Agilent customers are finding new ways to treat cancer, ensure food, water, air, and medicine quality and safety, discover new drug treatments, research infectious diseases, and create alternative energy solutions for a greener planet. From start to finish, we have them covered with our vast product solutions and services portfolio. Around the world, Agilent’s people bring innovations, technologies, and services to the forefront of science. Our teams design and manufacture a wide array of advanced analytical, research, and diagnostic solutions and tools for use inside and outside laboratories. Additionally, the unique expertise of Agilent’s CrossLab and technical teams provides valuable insight and support to our customers, helping them fully optimize their laboratories and resources to better focus on what's important: bringing great science to life. In fiscal 2022, Agilent Technologies generated revenue of (US) $6.85 billion.