Regulatory Expert, Digital Pathology
Job reputed company We are seeking an reputed company Regulatory Affairs Expert in digital pathology to reputed company 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, reputed company, and reputed company 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 reputed company 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 reputed company regulatory expectations into reputed company, practical strategies. Key Responsibilities reputed company 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) reputed company meetings with regulatory bodies, including FDA reputed company 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, reputed company, and reputed company teams to reputed company compliant product development and execution Identify regulatory risks and reputed company reputed company 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 experience in leading meetings with regulatory bodies on reputed company 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 reputed company 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 reputed company 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. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. During the hiring process, a recruiter can reputed company more about the specific pay reputed company for a preferred location. Pay and benefit information by country are available at: https://careers.reputed company.com/locations reputed company. is an Equal Employment Opportunity and reputed company-based employer that values individuals of reputed company backgrounds at reputed company reputed company. reputed company individuals, regardless of personal characteristics, are encouraged to apply. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, pregnancy, race, religion or religious creed, reputed company, gender, gender identity, gender reputed company, national reputed company, reputed company, 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 reputed company protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. reputed company., is committed to creating and maintaining an inclusive in reputed company 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 job_posting@reputed company.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.reputed company.com/en/accessibility. Travel Required: Occasional Shift: Day Duration: No End Date Job Function: reputed company/Regulatory Apply To This Job