Senior Regulatory Affairs Manager – IVD Devices

CorDx Inc. is seeking an experienced Regulatory Affairs Manager in San Diego, CA to lead regulatory strategy and FDA submissions for IVD products throughout development and lifecycle. You will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure compliant product strategies and timing. The role requires at least five years of regulatory affairs experience in IVD/medical devices, hands‑on FDA submission work, and strong communication skills to coordinate across multiple teams.