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Senior Regulatory Affairs Lead - Medical Software
Posted 1 hour 43 minutes ago by Medtronic plc
Permanent
Full Time
Government & Defence Jobs
Galway, Galway, Ireland
Job Description
Medtronic plc in Galway, Ireland, seeks a Senior Regulatory Affairs Specialist to lead software-based medical device submissions (FDA eSTAR) and EU Notified Body processes. You will craft regulatory strategies, liaise with cross-functional teams, and ensure compliance across global markets.
The role requires experience in preparing submissions, regulatory planning, and maintaining product files, with a focus on IEC 62304 and life-cycle processes.
Medtronic plc
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