The Product Reviewer will independently assess manufacturers' software lifecycle processes and technical documentation for medical device software. They are responsible for raising and closing out technical assessment findings while ensuring consistency with company methodology.
Plan and conduct QMS audits against ISO 13485, EU MDR, and UK MDR requirements. Document findings, review corrective actions, and provide clear conclusions to support certification decisions.
You will build and maintain a complex tech stack to streamline regulatory processes for medical technology. You will work cross-functionally to ship high-quality functionality at a high cadence while ensuring safety and compliance.
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.
