Senior Regulatory Affairs Lead - Medical Software

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.