Legit.Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end. You will design and defend our evidence strategy, lead CER/PMCF across EU and US, and drive submissions with minimal reliance on other teams.
Strong knowledge of MDR/FDA, GCP, and SaMD is essential. You will work with Quality, Regulatory, and Product Development teams to author CEPs/CERs, manage audits, and coordinate external consultants while maintaining scientific rigor and