The Specific Pay Range For A Preferred Location
RegulatoryExpert,DigitalPathology
Neural analysis suggests this role is
optimal for Senior candidates.
“Regulatory Expert, Digital Pathology at The Specific Pay Range For A Preferred Location. Skills: Digital pathology, Regulatory affairs, SaMD, AI/ML. Provide regulatory leadership for digital pathology products. Ensure global regulatory requirements are incorporated”
Industry & Context.
Risk mitigation strategies
Occasional travel
What They're Looking For.
Must Have
8+ years regulatory affairs experience, Demonstrated experience leading meetings with regulatory bodies, Demonstrated experience in digital pathology or software-based diagnostics, Understanding of SaMD, AI/ML regulatory frameworks, Understanding of global regulatory requirements
Nice to Have
Advanced degree in scientific or engineering
What You'll Do.
Provide regulatory leadership for digital pathology products
Ensure global regulatory requirements are incorporated
Define global regulatory strategies
Lead meetings with regulatory bodies
Provide regulatory guidance on clinical validation
Interpret and apply regulatory guidance for SaMD
Identify regulatory risks
Provide clear mitigation strategies
How You'll Work.
Team & Collaboration
Partner with R&D; Partner with Clinical; Partner with Quality; Partner with Commercial teams
Full Job Description
## **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, 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. **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 * 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 ## ## **Qualifications** * Bachelor’s degree in scientific or engineering discipline; advanced degree preferred. * 8+ years of regulatory affairs experience in IVDs or medical devices. * Demonstrated
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