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
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.
Additional Details
This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least June 8, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $124,160.00 - $232,800.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/RegulatorySimilar Jobs
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