Clinical Validation Specialist

As a Clinical Validation Specialist, you sit at the intersection of medicine, data, and regulation — designing the studies that demonstrate our software performs in the real world, with real pathologists, on real cases.

You will plan validation protocols, coordinate with partner laboratories, and turn study results into the evidence packages our regulatory team needs. This role is based out of our Sofia headquarters.

Responsibilities

• Author clinical validation protocols, including endpoints, sample size, and ground-truth strategy.
• Coordinate data collection and reader studies with partner laboratories and pathologists.
• Analyze study results and produce clear, traceable validation reports.
• Work with regulatory affairs to assemble evidence for CE IVDR and other submissions.
• Maintain meticulous documentation aligned with our ISO 13485 quality management system.

Required qualifications

• Degree in life sciences, biomedical engineering, medicine, or a related field.
• 2+ years of experience in clinical validation, clinical research, or medical device studies.
• Solid grasp of study design, biostatistics, and diagnostic performance metrics.
• Excellent written communication and a love of precise, auditable documentation.
• Comfort working with cross-functional teams across clinical, engineering, and regulatory.

Preferred qualifications

• Experience with IVDR, ISO 13485, or other medical device quality frameworks.
• Familiarity with digital pathology or diagnostic imaging.
• Experience running multi-reader, multi-case (MRMC) studies.

For this role, we value rigor, attention to detail, and a deep respect for the patients ultimately affected by every result we report.

Our perks

Flexible hybrid scheduling, open paid time off, private health insurance, a learning budget, and equity so the whole team shares in our success.

Digital Pathology Solutions is an equal opportunity employer. We make reasonable accommodations for candidates with disabilities and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, or any other category protected by applicable law.