A renowned global Medical Device Notified Body is currently in search of a Medical Device Auditor to join their expanding team across Europe. This role will be pivotal in driving the company's growth strategy and contributing to the success of their operations. You'll have the opportunity to immediately impact their European endeavors by collaborating with leading MedTech manufacturers.
Primary responsibilities:
- Conducting regulatory audits and evaluations of Clients, including Technical File Review, in accordance with EU directives (MDR) and the MDSAP.
- Assessing corrective actions, compiling reports, and preparing audit documentation for submission to the certification committee of the Notified Body.
- Managing projects for European-based Clients, involving quoting, project coordination, audit team management, and direct customer interaction.
Key requirements:
- A robust background in the production, validation, engineering, Design or development sectors of the Medical Device industry.
- Direct engagement with Quality Management Systems (QMS) within a Medical Manufacturer, with relevant experience in Active Medical Devices.
- A minimum of 4 years of hands-on experience in the medical device field to qualify for Notified Body Auditor status.
- Willingness to travel regularly, spending 3-5 nights a week across European regions.
- You must be based in a European country.
- A university degree in Engineering or Sciences, such as Biomedical, Electrical, Industrial, Biology, Chemistry, or Physics.
