Regulatory Expert, Digital Pathology

Job not on LinkedIn

🕒 Yesterday

🏄 California – Remote

🏄 California – Remote

💵 $124.2k - $232.8k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

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Agilent Technologies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🔬 Science

🧬 Biotechnology

💊 Pharmaceuticals

💰 $500M Post-IPO Debt on 2019-09

Science • Biotechnology • Pharmaceuticals

Agilent Technologies is a global leader in the field of analytical and laboratory instruments. The company offers a diverse range of products and solutions, including gas and liquid chromatography, mass spectrometry, lab supplies, and software and informatics. Agilent serves various industries, such as biopharma, food and beverage testing, clinical diagnostics, and environmental testing. Additionally, Agilent provides comprehensive services for lab management, maintenance, and instrument repair. They focus heavily on advancing science through sustainable solutions and supporting genomics, pathology, and cancer research with advanced technologies.

📋 Description

• 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

🎯 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

🏖️ Benefits

• eligibility for bonus • stock and benefits