---
title: 'Medical Device Auditor at Scarlet'
canonical: 'https://feeny.ai/job/medical-device-auditor-scarlet-london-s99qnr2m7q8t'
type: 'job'
last_seen: '2026-09-11'
---

# Medical Device Auditor at Scarlet

- **Company:** Scarlet
- **Location:** London, United Kingdom
- **Compensation:** £75k–£90k
- **Employment:** full-time
- **Posted:** 2026-09-09
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.ashbyhq.com/scarlet/14c67292-c2be-4f89-afae-e0e7dcd78632

## 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](https://www.linkedin.com/in/wrightsandy/) — 30 minutes.
- QMS audit exercise and discussion with [Felicia](https://se.linkedin.com/in/felicia-aldrin) — 60 minutes.
- Culture and values interviews with [James](https://www.linkedin.com/in/james-dewar-78758992/) and [Jamie](https://www.linkedin.com/in/jamie-cox-01458b3a/) — 30 minutes each.
- References and offer.

## About Scarlet

## Company Overview
- **One-liner**: Scarlet is the only Notified Body specialised in certifying AI-powered software as a medical device (SaMD) for the EU and UK markets.
- **Entity Type**: Private (Series A, July 2024)
- **Headquarters**: London, United Kingdom, with a second office in Amsterdam, Netherlands.
- **Founded**: 2020
- **Founders**: James Dewar (Co-founder)

## Core Business
- **Primary Industry**: Healthcare IT, Medical Device Certification, Regulatory Compliance
- **Target Customers**: B2B (Healthtech and MedTech companies building AI and SaMD solutions)
- **Mission Statement**: To hasten the transition to universally accessible healthcare by enabling customers to get their life-changing technology to the people who need it.

## Products & Services
- **EU & UK Medical Device Certification**: Acts as a Notified Body (under EU MDR 2017/745) and an UK Approved Body to certify AI medical devices and SaMD. [scarlet.cc](https://www.scarlet.cc/)
- **ISO 13485 Certification**: Accredited to issue ISO 13485 certificates for quality management systems in medical devices.
- **Continuous Iteration Support**: Provides a regulatory pathway that allows for the frequent, iterative product releases required for modern AI products, a key differentiator from traditional Notified Bodies.
- **Certificate Transfer Service**: Facilitates the transfer of existing medical device certifications to Scarlet in as little as 4 weeks. [scarlet.cc](https://www.scarlet.cc/)

## Market Standing
- **Total Funding**: USD $26.6M across three rounds (Pre-Seed, Seed, Series A).
- **Key Metric - Total Funding**: $26.6M. Key Metric - Headcount: ~57 employees as of mid-2025, with 50% year-over-year growth.
- **Notable Investors**: Atomico (led the $17.5M Series A in July 2024), Creandum (led the $7M Seed round).
- **Growth Signals**: Rapid headcount growth (+50% YoY). A surge in active job postings (up 500% year-over-year). LinkedIn follower growth of +126% year-over-year. Operates across 9 countries, indicating strong remote-first hiring capacity.

## Competitive Advantages
- **Unique Market Position**: The only Notified Body in Europe purpose-built and specialised for AI and SaMD, giving it a unique regulatory and technical moat.
- **High Regulatory Trust**: Led by a board and panel of former global regulators, including the ex-Director of Medical Devices at the UK’s MHRA and the ex-CEO of BSI. This grants unparalleled credibility and deep insights into regulatory requirements. [scarlet.cc](https://www.scarlet.cc/company)
- **Impartiality Panel & Advisors**: Includes former heads of the UK’s MHRA and EU regulatory experts, ensuring adherence to the highest standards. [scarlet.cc](https://www.scarlet.cc/company)
- **Process Speed**: Claims to be significantly more efficient and faster than traditional Notified Bodies, which is critical for the fast-paced AI industry.

## Strategic Focus
- **Scaling Certification Capability**: Expanding its team to handle a growing pipeline of AI device submissions across the EU and UK.
- **Deep Specialisation in AI**: Continues to build expertise in niche areas like radiology, clinical decision support, and cybersecurity for medical AI.
- **Global Expansion**: Growing its influence as a key regulator for the next generation of software-based healthcare technology.

## Why Work Here
- **Mission-Driven**: The company has a strong, clear vision of transforming global healthcare, which is a powerful motivator for employees in technical and operational roles.
- **High-Growth Environment**: With 18 active job postings and a 500% increase in openings year-over-year, this is a company in a rapid scale-up phase, offering significant career growth opportunities.
- **Distributed & International Team**: With offices in London and Amsterdam and staff spread across 9 countries, Scarlet supports a hybrid/remote-friendly work culture.
- **Senior Leadership Access**: The small but rapidly growing team (57 people) means employees have direct access to top-tier leadership and can have an outsized impact.
- **Engineering Culture**: Actively hiring for technical roles (Head of Engineering, Platform team), with a focus on "problem-centricity" and high performance, indicating a mature, outcome-focused engineering culture. [scarlet.cc](https://www.scarlet.cc/careers)

## Sources
1. [scarlet.cc](https://www.scarlet.cc/)
2. [scarlet.cc](https://www.scarlet.cc/company)
3. [scarlet.cc](https://www.scarlet.cc/careers)
4. [LinkedIn - Scarlet](https://uk.linkedin.com/company/scarlet-comply)
5. [Ashby - Scarlet Careers](https://jobs.ashbyhq.com/scarlet/4a2e45c2-54f3-4a7a-bee1-b71e34ec7db9)

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