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.
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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.
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