Senior Regulatory Affairs Lead, Medical Devices

Life Science Recruitment is seeking a Senior Regulatory Affairs Specialist for a growing medical device organisation in Ireland. The role covers all regulatory activities including product certification, compliance, and maintenance of the Quality Management System.

You will lead submissions for EU/UK/US, maintain technical files, manage vigilance and risk management, and support CE audits. Strong knowledge of EN/MDD/MDR, ISO13485, FDA requirements, and QMS internal auditing is essential.