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Scarlet via Ashby

Medical Device Auditor

Level not stated LondonStockholm
still open verified 1d ago posted 5d ago checked 2h ago
Apply at jobs.ashbyhq.com

This is the employer's own posting, not a copy on a job board.

What we know

Is it still open?

Confirmed still open

Last checked 1d ago — checked against the employer's own applicant tracking system, which is the company answering directly.

We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.

Check this listing's status as JSON

How old is it?

Posted 5d ago

The date the source published, not the day we noticed it (2026-09-09). Last seen at its source 2h ago.

Is it remote?

Remote

That is the location the employer filed this posting under. Quoted as written — we do not re-word the source's own location.

Who may apply?

London, Stockholm

The description states no restriction of its own. This is the source's own tag.

Pay not stated

Similar roles pay $110–120/hr

Middle 50% of 9 listings that do state pay — Finance · all levels · United Kingdom · USD/hour. This employer has published no salary; this is what comparable listings we hold disclose, never converted between currencies or periods. How this is calculated.

Skills named in the ad

Troubleshooting

Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.

Carried by 1 source

The listing

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

  1. Introductory call with Sandy — 30 minutes.

  2. QMS audit exercise and discussion with Felicia — 60 minutes.

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

  4. References and offer.

Apply at jobs.ashbyhq.com