Scarlet is a medical technology certification company that combines clinical, technical and regulatory expertise with AI agents and software to help ambitious technology companies certify AI-enabled medical devices faster without lowering safety standards. You'll join a collaborative team building the infrastructure that makes rigorous certification repeatable at scale.
Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices, under EU MDR, UK MDR, and relevant IEC standards.
Raise and close out technical assessment findings with manufacturers, explaining regulatory requirements clearly and constructively.
Deliver consistent, high-quality assessments that match Scarlet's methodology and values, working independently with flexible scheduling.