At a Glance
- Tasks: Audit medical device manufacturers and ensure compliance with quality management systems.
- Company: Scarlet, a forward-thinking company revolutionising medical technology certification.
- Benefits: Competitive salary, training opportunities, and a chance to impact patient safety.
- Other info: Limited travel, dynamic work environment, and strong career growth potential.
- Why this job: Join a team that accelerates the delivery of safe medical devices to patients.
- Qualifications: Degree in a relevant field and experience in medical device auditing.
The predicted salary is between 45000 - 55000 £ per year.
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.
As a Medical Device Auditor at Scarlet, 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 — 60 minutes.
- Culture and values interviews with James and Jamie — 30 minutes each.
- References and offer.
Medical Device Auditor in London employer: Scarlet
Scarlet is an exceptional employer that fosters a collaborative and innovative work culture, where your contributions as a Product Designer will directly impact the future of health technology. With a strong focus on employee growth, you will have access to continuous learning opportunities and the chance to work alongside industry experts in a dynamic environment. Located in a vibrant area, Scarlet offers unique advantages such as flexible working arrangements and a commitment to user-centered design, making it a rewarding place to advance your career.
