Medical Device Validation Lead

To support a growing team, the full-time Medical Device Workflow & Validation Lead will manage client reviewer relationships, lead validation sessions, and translate reviewer needs into actionable workflows 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 processes Strong understanding of medical-device submission documentation Experience gathering requirements and working directly with clients or domain stakeholders Ability to translate complex domain needs into clear, testable product requirements Experience conducting user acceptance testing or structured software validation