Sr Regulatory Affairs Specialist

Role: Senior Specialist, Regulatory Affairs (CDx), supporting regulatory submissions and strategy for in vitro companion diagnostic medical devices. Responsibilities: develop regulatory strategies, prepare and review submissions (IDE, PMAs, sPMAs, SRDs), manage agency interactions, support product lifecycle compliance, and review validation and technical documents. Requirements: Bachelor's degree with 3+ years or Master's with 1+ year of professional experience; experience with FDA, particularly CDRH, and regulatory submissions; knowledge of FDA IVD requirements, validation, and device design control. Preferred: direct experience with FDA submissions (IDE, PMA), cross-functional project management involving assay/instrumentation/software, companion diagnostics expertise, and strong communication skills. HighValue: focus on in vitro diagnostics, FDA regulatory processes, companion diagnostics, validation/clinical data, and cross-disciplinary collaboration. WorkSetup: not specified.