Regulatory Expert (Digital Pathology)

Location: US-CA-Carpinteria; remote work option available

Salary: $124,160–$232,800 per year, plus eligibility for bonus, stock, and benefits

Company

hirify.global is the hiring organization for this full-time Quality/Regulatory position.

What you will do

• Provide regulatory leadership for digital pathology products, including whole slide imaging systems, image analysis algorithms, and integrated diagnostic workflows.
• Define and execute global regulatory strategies and support FDA, EU IVDR, and international submissions.
• Lead meetings with regulatory bodies, including the FDA.
• Provide guidance on clinical validation, study design, and performance evidence for digital pathology products.
• Interpret and apply requirements for Software as a Medical Device, AI/ML diagnostics, cybersecurity, and algorithm lifecycle management.
• Partner with R&D, Clinical, Quality, and Commercial teams to identify risks and deliver mitigation strategies throughout the product lifecycle.

Requirements

• Bachelor’s degree in a scientific or engineering discipline; an advanced degree is preferred.
• At least 8 years of regulatory affairs experience in IVDs or medical devices.
• Demonstrated experience leading meetings with regulatory bodies on complex topics.
• Demonstrated experience in digital pathology or software-based diagnostics is required.
• Strong understanding of SaMD, AI/ML regulatory frameworks, and global regulatory requirements.
• Work location: US-CA-Carpinteria, with an option to work remotely.

Culture & Benefits

• Full-time weekly schedule with a day shift.
• Occasional travel is required.
• Eligibility for bonus, stock, and benefits.
• Equal employment opportunity and an inclusive workplace.