QA/Regulatory Leader – Medical Devices

CTL Amedica Corporation seeks an experienced Quality/Regulatory Manager to lead the QA/Regulatory staff and guide compliance across the organization. You will interpret requirements per FDA QMSR, ISO 13485:2016, and ISO 14971, and act as the primary liaison with regulatory bodies. You will coordinate external audits, manage CAPA and non-conforming materials, and oversee product labeling, release, and post-market surveillance activities.