Senior Clinical Affairs Manager, Samd
Hace 4 días
Málaga, Andalucia, España
Legit.Health
Jornada completa
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Legit. Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end, acting as the expert in the room for European and US submissions.
The role requires leading CEP/CER development, post-market follow-up, and regulatory strategy with cross-functional teams. You will design and defend our clinical evidence approach, work with MDR and FDA frameworks, and ensure high scientific rigor across clinical data, literature reviews, and SAP/SAR
The role requires leading CEP/CER development, post-market follow-up, and regulatory strategy with cross-functional teams. You will design and defend our clinical evidence approach, work with MDR and FDA frameworks, and ensure high scientific rigor across clinical data, literature reviews, and SAP/SAR