Medical Device Auditor

Overview

In this role, you will assess and improve quality management systems for software-based medical devices, ensuring regulatory compliance and robust processes. You’ll work within a cross-functional context to strengthen QMS and support ongoing safety and performance of SaMD products. This position offers remote-friendly arrangements and a chance to influence regulatory readiness and quality outcomes in a fast-paced environment. You will collaborate with the client’s team to drive continuous improvement and maintain alignment with MDR requirements.

Pay / Benefits

• remote-friendly
• share options
• EV and cycle to work scheme

Responsibilities

• Conduct QMS audits against ISO 13485 and related standards to verify conformance
• Evaluate and improve QMS processes for software-based medical devices (SaMD)
• Ensure compliance with EU MDR and UK MDR for QMS across the product lifecycle
• Collaborate with cross-functional teams to address findings and drive corrective actions
• Support regulatory readiness activities and documentation maintenance

Key requirements

• Medical Device Industry Experience (4+ years)
• ISO 13485 QMS Auditing/Management
• EU MDR / UK MDR for QMS
• Software & SaMD Expertise desirable

• ISO 13485 QMS auditing
• Regulatory compliance (EU MDR, UK MDR)
• SaMD knowledge
• Software-based medical device understanding

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