Medical Device Validation Lead

Job Summary

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