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Scarlet

Scarlet

Certification framework for software medical devices

Market Access Operations

Full-Time
£60k - £90k/yr
Mid
London, UK
In Person

About the job

Requirements
  • At least three years’ experience in a commercial, strategy or business operations role, ideally in a start-up or other fast-moving environment.
  • Experience leading complex, multi-part projects from initial idea through delivery, involving internal and external teams.
Responsibilities
  • Research new markets, regulatory approvals and certifications, assess their potential value to customers and make prioritisation decisions on how to sequence them.
  • Lead new approval applications from start to finish. Coordinate Scarlet teams, external experts and regulatory bodies, resolve blockers and keep several applications moving at once.
  • Identify manufacturers who need new approvals, close deals with the first customers and coordinate their journey through a service Scarlet is delivering for the first time.
  • Build repeatable processes, tooling and knowledge so that each new approval makes the next one easier.
  • Hand new approvals to the teams that will run them at scale, including the documentation, decisions and regulatory relationships needed for delivery.
Desired Qualifications
  • Experience evaluating opportunities from strategic and commercial perspectives and making clear recommendations.
  • Experience researching unfamiliar systems, synthesising incomplete information, analysing data and turning findings into concrete plans.
  • Experience building or improving operational processes and tooling so that repeated work becomes faster.
  • Experience writing concisely and communicating complicated topics clearly.

About the company

Scarlet provides a platform-based service for certifying Software Medical Devices. It targets manufacturers of medical software and regulatory bodies, offering a framework that enables scalable, continuous development and monitoring of software products to meet regulatory requirements. The platform streamlines the certification process by allowing both manufacturers and regulators to build, certify, and oversee software in a coordinated, ongoing cycle rather than a one-time check. Scarlet differentiates itself by addressing gaps in the current regulatory approach to fast-evolving health software, emphasizing scalable, continuous monitoring and collaboration between sponsors and regulators. Its goal is to get safe, life-saving medical software to patients faster while helping make healthcare more accessible and affordable for people everywhere.

Company Size

51-200

Company Stage

Series A

Total Funding

$27.4M

Headquarters

London, United Kingdom

Founded

2020

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Simplify's Take

What believers are saying

  • Scarlet certified TORTUS's first UKCA Class IIa ambient voice device on 24 June 2026.
  • Scarlet's 3 September 2026 blog cadence signals active demand from AI device builders.
  • LinkedIn showed 8,814 followers and 51-200 employees on 31 August 2026.

What critics are saying

  • Scarlet depends on regulated-review volume; slower MDR filings hit revenue within 12 months.
  • Tougher scrutiny after TORTUS's 24 June 2026 UKCA IIa certification compresses turnaround expectations.
  • One high-profile certification failure would destroy Scarlet's trust moat and notified-body franchise.

What makes Scarlet unique

  • Scarlet issued its first EU MDR certificate on 13 November 2024.
  • Scarlet is UK Approved Body 8536 and recognized for FDA 3P510k reviews.
  • Scarlet certifies AI medical software for EU MDR, UK MDR, ISO 13485.

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Benefits

Health Insurance

401(k) Retirement Plan

Remote Work Options

Paid Vacation

Flexible Work Hours

Wellness Program

Mental Health Support

Conference Attendance Budget

Family Planning Benefits

Fertility Treatment Support

Professional Development Budget

Stock Options

Company Equity

Health Savings Account/Flexible Spending Account

Phone/Internet Stipend

Growth & Insights

Headcount

6 month growth

6%

1 year growth

3%

2 year growth

10%