Product Reviewer MDR
at X4 EngineeringX4 Engineering are partnered with a growing EU-based Notified Body to source a qualified Product Reviewer join their MDR team, focusing on Active medical devices. This is an exciting role with a growing organization, where you'll have the chance to take on Project Management responsibilities, and approve cutting-edge AI-based medical devices and medical software. This is a fully remote role, for which the candidate can be based anywhere in the UK or Europe. The ideal candidate will have 2+ years' Notified Body experience performing technical file review. This is essential. Product Reviewer MDR – Key Responsibilities
- Conduct and evaluate product assessments against MDR requirements for Class I-III Active medical devices
- Work cross-functionally with Clinical personnel and Project Managers to deliver timely & high-quality reports
- Maintain active monitoring of the regulatory landscape and report to the team any new publications/requirements identified in your specific area of device expertise Compensation & Travel
- Salary: £70,000-£80,000 + annual bonus
- Travel: Quarterly or biannual travel to Headquarters in Europe Education & Skills Required
- Minimum of 2+ years' Product/Technical File Review experience within a Notified Body
- University degree in a scientific or engineering field
- Professional proficiency in the English Language is a necessity
- Competence/experience with Medical Software and AI-based devices (desirable) Candidates will require permanent residency and/or citizenship of the European country they reside in to be considered for this opportunity. Apply now or feel free to drop me any questions. Furthermore, successful referrals will earn up to a (€/£1000 reward, so please do share with your network if you have a contact who could be interested!)
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