On behalf our client, we are currently recruiting for a Medical Devices Inspector. This is a 3 year contract role. The role is hybrid - 3 days in Dublin office and 2 days remote. There is some national and international travel. Full driving licence required. ROLE SUMMARY
Reporting to the Medical Device Inspection Operations Manager, the 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 content below represents a broad guideline for the role of Medical Devices Inspector. Some aspects may be subject to change in accordance with business needs.
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. QUALIFICATIONS AND EXPERIENCE
A 3 rd level degree in an engineering or other relevant scientific discipline
Auditing/Inspection experience in medical devices/technology or related healthcare industry with a strong working knowledge of the regulatory environment and relevant quality and technical standards
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
A full driving licence
Knowledge of relevant European and National legislation
A self-starter, capable of excellent communication, negotiation and decision making
Highly motivated and with the ability to manage deadlines
Excellent organisational, formal technical writing, and administrative skills
Demonstrable initiative and team working capabilities
-In addition, the following would be considered an advantage;
Post graduate qualification in a relevant scientific discipline
A lead auditor qualification
Experience in the design, manufacture and/or quality assurance of medical devices
Experience in the validation of manufacturing processes
Experience in the validation of sterilisation of medical devices
Knowledge of Notified Body designation and monitoring
Availability to travel for national and international inspections is a requirement in this role.
For full details contact Linda at 1 or email your CV to . Thornshaw Scientific is a division of the CPL Group
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