Medical Device Auditor

Scarlet; Stockholms kommun; On-site; SEK 989,000 - 1,186,000; Full time

Job summary

Scarlet is seeking a Medical Device Auditor to assess manufacturers’ quality management systems and draft clear conclusions for certification decisions. You will be trained in Scarlet’s audit methods and tools, and your work combines evidence review with practical discussions about processes.

Travel will be limited, though occasional trips may be required to reach patients safely. This role emphasizes thorough documentation, constructive communication of findings, and the ability to review

Qualifications

• Bachelor’s 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 clearly in writing and in conversation.
• Experience with software demonstrating knowledge of software design, validation, testing and interactions with its operating environment.

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.

Skills

Audit experience

Regulatory knowledge

Technical writing

Communication skills

Education

Bachelor’s degree in science/engineering/medicine

Tools

Software development background

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, 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.

Compensation Range: £75K - £90K