Scarlet

Own the structure, navigation, and presentation of the customer-facing knowledge base to improve guidance accessibility. Partner with subject matter experts to create structured content models and taxonomies that support both human and AI consumption.

Establish and maintain commercial relationships with regulatory consultants and attorneys to drive advocacy for Scarlet. Develop strategies to increase awareness and adoption of the company's medical AI assessment services within the US ecosystem.

Develop high-quality educational content and training materials to help medical device innovators navigate complex regulatory requirements. Lead structured discussions to clarify regulatory standards and ensure consistent alignment with audit expectations.

Specialists will join a roster to provide targeted clinical insight on medical devices during regulatory assessments, typically for short engagements on an as-needed basis. Your input is crucial for ensuring certified devices demonstrate appropriate clinical performance, safety, and benefit for their intended use.

Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR. Provide clear, structured audit documentation and evidence-based conclusions.