On behalf of my client, we are working with them on a new opportunity for a Medical Devices Inspector.
Reporting to the Medical Device Inspection Operations Manager, you as Medical Devices Inspector will be primarily responsible for:
o Planning and conducting proactive and reactive inspections of manufacturers and other economic operators as part of the market surveillance activities for medical devices.
o Execution of inspections relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities.
o Execution of inspections arising from the ongoing surveillance and monitoring programme for Notified Bodies, including observation of audits conducted by the Notified Bodies.
o Ensuring alignment of inspection activities with other assessment activities across the Medical Devices Department and appropriate interaction with relevant teams and sections in the preparation, conduct and follow up from medical device inspections.
The role of a Medical Device Inspector is to identify and evaluate issues at sites inspected, nationally and internationally, that may result in.
- medical devices being placed on the market that are non-compliant with the requirements of the national legislation (in Ireland), European Community Directives, European Regulations, harmonised standards, and other relevant guidance.
- notified bodies, economic operators and other entities that are non-compliant with their obligations and the requirements of the national legislation (in Ireland), European Community Directives, European Regulations, harmonised standards, and relevant guidance.
If this sounds like your ideal next move, then you need to meet the criteria below and we would love to speak with you and discuss this exciting role in more detail.
o A 3rd level degree in an engineering or other relevant scientific discipline
o Auditing/Inspection experience in medical devices/technology or related healthcare industry with a strong working knowledge of the regulatory environment and relevant quality standards
o A minimum of two years' relevant experience in the medical devices sector, pharmaceutical industry or notified bodies sector or relevant regulatory experience in the field of medical devices registration and/or vigilance
o o A full driving licence
o Knowledge of relevant European and National legislation
o o A self-starter, capable of excellent communication, negotiation and decision making
o o Highly motivated and with the ability to manage deadlines
o o Excellent organisational and administrative skills
o o Demonstrable initiative and team working capabilities
Full job spec available on request.
Contact Tina at 3583 1 2784701 or email your CV to firstname.lastname@example.org
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com