Medical Device Inspector
Our Client an Irish Regulatory Body requires a Medical Device Inspector to join their Medical Device Compliance Team.
• Plan and conduct proactive and reactive audits of manufacturers and other economic operators as part of the market surveillance activities for medical devices
• Execution of audits relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities
• Execution of audits arising from ongoing surveillance and monitoring programme for Notified Bodies, including observation of audits conducted by the Notified Bodies
• Carrying out audits of custom made, Class I and other medical devices relating to the registers
• Identify and evaluate issues at sites audited, in Ireland and abroad, that may result in medical devices non-compliant with the requirements of National legislation (in Ireland), European Community Directives, Regulations and Guidance being place on the Irish or European market.
These sites may include;