24 ott - Lombardia
Newel Health
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.
#J-18808-Ljbffr