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    • Experience with medical device software.
    • As a Medical Device Auditor at Scarlet based out of either our London or Sweden office, you will audit medical device…
    • View all Scarlet jobs - London jobs - Auditor jobs in London
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    • Support continuous improvement of affiliate quality processes.
    • Ensure effective handling of product quality complaints, temperature excursions and distribution…
    • This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices.
    • Proficient in Microsoft Office and electronic quality management systems.
    • Ability to make independent, risk-based quality decisions and influence stakeholders…
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    • This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and…
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    • Significant experience (typically 8+ years) within medical device industry.
    • Medical Devices: Advising on medical device quality and regulatory requirements,…
    • Drive clinical quality and performance, supporting the achievement of quality, productivity and TPL targets.
    • We’re seeking an experienced and motivated Clinical…
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    • Managing regulatory documentation and technical files for medical device submissions.
    • Scope to develop deeper expertise in medical device regulatory frameworks…
    • Experience working within an FDA Class II/III medical device environment would be advantageous.
    • Oversee the completion and maintenance of technical and medical…
    • Manage the medical quality operational and capital expenditure in line with budgets and business plans.
    • Through leading by example, ensure that the quality…
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    • Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
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    • Domain: Class III medical device · regulatory affairs.
    • 3–7 years' experience in regulatory affairs, quality assurance or related compliance roles within medical…
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    • Support customer inspections, witness testing and quality reviews.
    • Free, secure parking with EV charging.
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    • Demonstrated experience in medical device regulatory affairs or compliance (medical device or pharmaceutical background).
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Medical Device Auditor
Scarlet
London
£75,000 - £90,000 a year
Full-time
Apply on company site

Job details

£75,000 - £90,000 a year
Full-time
London

Full job description

We pull medical technology from the future to solve human health.


Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.

Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.

About the role

As a Medical Device Auditor at Scarlet based out of either our London or Sweden office, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. You’ll receive training in Scarlet’s audit methods and tools. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice. Travel will be limited, though occasional trips may be required. You will help safe devices reach patients sooner.

Responsibilities

  • Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements.

  • Review records and interview teams to assess whether their processes meet the requirements.

  • Document evidence, findings and conclusions in clear, timely audit reports.

  • Explain findings constructively and keep customers informed throughout the audit.

  • Review corrective actions and the evidence needed to close findings.

Required qualifications

  • A degree in a relevant scientific, engineering or medical discipline.

  • At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS.

  • Working knowledge of EU MDR or UK MDR requirements for quality management systems.

  • Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation.

  • Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment.

Preferred qualifications

  • Experience conducting audits for a certification or notified body.

  • Experience with medical device software.

Interview process

  • Introductory call with Sandy — 30 minutes.

  • QMS audit exercise and discussion with Felicia — 40 minutes.

  • Culture and values interviews with James and Jamie — 30 minutes each.

  • References and offer.

Compensation Range: £75K - £90K

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