Senior SaMD Quality Auditor - ISO 13485 & EU MDR (Remote)

Cure Talent Limited; Greater London; Remote; GBP 60,000 - 80,000; Full time

Benefits offered by this job

Remote working

Job summary

Cure Talent Limited is partnering with a growing medical device certification organisation specialising in SaMD and AI-enabled technologies. This UK-based role focuses on Stage 1 and Stage 2 ISO 13485 and EU MDR audits, with a few audit days per week plus reporting and follow-up.

Ideal candidates have hands-on SaMD QA experience, ISO 13485 knowledge, and a mindset geared to external auditing. Some travel to client sites and the London office may be required.

Qualifications

• Proven QA experience in medical devices.
• Hands-on SaMD experience incl software development, validation and QC.
• Deep knowledge of ISO 13485 and Medical Device QMS.
• Experience auditing in regulated medical device environments.
• Degree in science, engineering or related technical field.
• Knowledge of EU MDR, ISO 14971; familiarity with IEC 62304 and IEC 82304-1.

Responsibilities

• Conduct Stage 1 and Stage 2 audits against ISO 13485 and EU MDR.
• Plan and lead audit activities; review docs and interview stakeholders.
• Produce clear audit reports and communicate findings to manufacturers.
• Objectively assess nonconformities with evidence support.
• Collaborate with Quality, Regulatory, Software Eng and leadership teams.
• Manage audit activity end-to-end including prep, delivery, reporting and follow-up.

Skills

Quality Assurance

SaMD experience

Audit experience

Regulatory knowledge

Software development understanding

Communication skills

Judgement/assessment

Education

Science/Engineering degree

Job description

Cure Talent Limited is partnering with a growing medical device certification organisation specialising in SaMD and AI-enabled technologies. This UK-based role focuses on Stage 1 and Stage 2 ISO 13485 and EU MDR audits, with a few audit days per week plus reporting and follow-up.

Ideal candidates have hands-on SaMD QA experience, ISO 13485 knowledge, and a mindset geared to external auditing. Some travel to client sites and the London office may be required.