To support a growing team, the full-time Medical Device Workflow & Validation Lead will manage client relationships, lead validation sessions, and translate reviewer needs into actionable requirements while working remotely within the continental United States. Key responsibilities: Build strong working relationships with client reviewers and establish a structured feedback process Lead discovery and validation sessions using prototypes and working software Validate proposed requirements and workflows before development begins Required qualifications: Previous experience as a medical-device reviewer with knowledge of regulatory review and quality assurance Strong understanding of medical-device submission documentation and review processes Experience gathering requirements and working directly with clients or domain stakeholders Ability to translate complex domain needs into clear, testable product requirements Must be authorized to work in the United States and have lived in the US for 3 or more consecutive years