Regulatory Expert, Digital Pathology

This is a fully remote position, open to applicants in California.

📋 Description

• Provide leadership in regulatory aspects for digital pathology products, which encompass whole slide imaging systems, image analysis algorithms, and integrated workflows.

• Ensure that global regulatory requirements are integrated early in the development process.

• Develop and implement global regulatory strategies and assist with submissions to FDA, EU IVDR, and other international markets.

• Facilitate meetings with regulatory entities, including the FDA.

• Offer regulatory advice on clinical validation, study design, and performance evidence requirements for digital pathology.

• Analyze and apply regulatory guidelines for Software as a Medical Device (SaMD), AI/ML diagnostics, cybersecurity, and the management of algorithm lifecycles.

• Collaborate with R&D, clinical, quality, and commercial teams to promote compliant product development and execution.

• Identify regulatory risks and present clear strategies for mitigation along with recommendations to leadership.

⛳️ Requirements

• A Bachelor’s degree in a scientific or engineering field; an advanced degree is preferred.

• Over 8 years of experience in regulatory affairs related to IVDs or medical devices.

• Proven experience in leading discussions with regulatory bodies on complex subjects.

• Demonstrated expertise in digital pathology or software-based diagnostics is essential.

• Strong comprehension of SaMD, AI/ML regulatory frameworks, and global regulatory standards.

🏝️ Benefits

• Eligibility for a bonus.

• Stock options and additional benefits.