Medical Device Auditor

Scarlet; Greater London; Sur place; GBP 60 000 - 80 000; Plein temps

Résumé du poste

Scarlet is seeking a Medical Device Auditor based in London or Sweden to audit medical device manufacturers’ quality management systems against ISO 13485, EU MDR and UK MDR requirements. You’ll review records, interview teams and document evidence to reach clear conclusions supporting certification decisions.

You’ll receive training in Scarlet’s audit methods and tools; travel will be limited. A degree in a relevant field and at least four years’ experience in the medical device industry (two

Qualifications

• 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.

Responsabilités

• Plan and conduct audits of QMS against ISO 13485, EU MDR and UK MDR requirements.
• Review records and interview teams to assess process conformance.
• Document evidence, findings and conclusions in audit reports.
• Explain findings constructively and keep customers informed throughout the audit.
• Review corrective actions and evidence needed to close findings.

Connaissances

Audit experience

Regulatory knowledge

Technical writing

Software understanding

ISO 13485 knowledge

Formation

Science/Engineering/Medicine degree

Description du poste

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

1. Introductory call with Sandy — 30 minutes.

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

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

4. References and offer.