Regulatory Affairs SaMD Portfolio Manager
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.
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.