Medical Device Inspector

Recruiter
Life Science Recruitment
Employment Type
Contract
Salary
Not disclosed
Life Science Recruitment logo

Medical Device Inspector
Our Client an Irish Regulatory Body requires a Medical Device Inspector to join their Medical Device Compliance Team.

Responsibilities
• 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;

  • Manufacturers of medical devices
  • Authorised Representatives
  • Contract Sterilisation sites
  • Notified Bodies

Requirements
• Degree in an engineering or relevant life science discipline
• Auditing experience in medical devices/technology or related healthcare products with a good knowledge of the regulatory environment and relevant quality standards
• A minimum of two years’ experience is required in the medical devices, pharmaceutical industry or notified bodies sector or relevant regulatory experience in the field of medical devices registration and/or vigilance
• Experience in the design, manufacture and/or quality assurance of medical devices
• A self-starter, capable of excellent communication, negotiation and decision making
• Highly motivated and with the ability to manage deadlines
• Excellent administrative and organisational skills
• Demonstrable initiative and team working capabilities
• A full driving license

For more information please contact Sinéad Cullen on or