Quality & Regulatory Operations Lead

This role serves as a supervisor within the QARA function, providing oversight and guidance to strengthen communication, alignment, and execution across the team. Radformation continues to scale, The QARA Operations Lead will coordinate key quality and regulatory deliverables, ensuring they stay aligned with product development timelines. You will work closely with the VP of Regulatory Affairs and cross-functional partners to track progress, support design control activities, and maintain audit-ready documentation across QARA. The role involves organizing and managing timely completion of QARA tasks, including CAPAs and DHF deliverables, coordinating due dates, dependencies, and status updates to align QARA work with project schedules, maintaining teamwide deliverable trackers, and partnering with deliverable owners to keep status current and identify risks early.