Regulatory Affairs SaMD Portfolio Manager

2 giorni fa

Lombardia, Italia Newel Health Srl Tempo pieno 110.000 € - 140.000 € Contratto

Newel Health Srl seeks a Regulatory Affairs Portfolio Manager to own regulatory strategy and the technical file for our medical device software, from classification through submission and post-market maintenance.

You will partner with internal teams, notified bodies and authorities, ensuring compliance across EU MDR and FDA SaMD frameworks while coordinating audits and risk management.