Product Reviewer MDR

X4 Engineering; United States; Remote; GBP 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Travel opportunities

Zusammenfassung

X4 Engineering is seeking a Product Reviewer MDR to join their MDR team, focusing on Active medical devices. The role supports project management tasks and approvals for AI-based medical devices and medical software, with fully remote work available across the UK and Europe.

The ideal candidate has 2+ years of Notified Body experience performing technical file reviews, a science/engineering degree, and strong English language skills. Some travel to Europe is expected for headquarters discussions.

Qualifikationen

• 2+ years' Notified Body experience performing technical file review.
• University degree in a scientific or engineering field.
• Professional proficiency in English is a necessity.
• Competence/experience with medical software and AI-based devices is desirable.

Aufgaben

• Conduct and evaluate product assessments against MDR requirements for Class I-III Active medical devices.
• Collaborate with Clinical personnel and Project Managers to deliver timely, high-quality reports.
• Monitor regulatory developments and report new requirements relevant to device expertise.

Kenntnisse

Notified Body experience

Regulatory reporting

Project management

Medical software familiarity

AI-based medical devices

Ausbildung

Bachelor's degree in science or engineering

Jobbeschreibung

X4 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

• 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.

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!)