Join our client, an active certification body, as they establish themselves as a Notified Body for medical devices.
Be part of building and growing the Notified Body together, ensuring compliance and supporting with the MDR designation, and have a seat at the table to establish processes and set the business structure.
This is an exciting opportunity for someone who is ready to take the next step in their career within a Notified Body, with varied challenges and a huge level of flexibility!
- Support with the monitoring and implementation of applicable legislations and standards
- Ensure that processes required for the management system are established, implemented and maintained
- Handling of complaints and initiation of CAPAs
- Identify and minimise risks, and review of the Risk Management report
- Communication with authorities and accreditation bodies
- Supporting with the determination of the organisational structure
- Assessment of yearly performance
- Flexible remote working contract – work from anywhere in Europe!
- The chance to have a voice and really be involved in building and growing the company together
- Short reporting line and the ability to make change and action things quickly, with lots of open table discussions
- Reports and works very closely alongside the Managing Director & Head of Notified Body
- A degree in the medical, scientific (or equivalent) field
- 3+ years of experience within a Notified Body (additional experience in a medical device manufacturer is desirable)
- Lead auditing experience
- Fluency in English
- Knowledge of regulatory requirements and medical device standards (e.g. ISO 13485, EU-MDR, ISO 14971)