Contract

Clinical Specialist

Expert Roster

Scarlet

Scarlet

51-200 employees

Certification framework for software medical devices

No salary listed

Remote in UK

Remote

Bachelor's

Category
Biology & Biotech (1)
Required Skills
Nursing

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Requirements
  • A degree in clinical medicine, nursing, or dentistry.
  • Certified specialisation in a medical field.
  • Current registration as a medical practitioner.
Responsibilities
  • Provide targeted clinical insight on medical devices during regulatory assessments.
  • Review or discuss specific device or assessment questions during short, as-needed engagements.
  • Help ensure that certified devices demonstrate appropriate clinical performance, safety, and benefit for their intended clinical use.

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 Jobs

Simplify's Take

What believers are saying

  • 2025 Class III certification for Skin Analytics DERM proves high-acuity regulatory capability.
  • June 2025 Feebris change certificate in two weeks shows speed matters to customers.
  • June 2026 TORTUS UKCA certification expands Scarlet's UK market credibility.

What critics are saying

  • Regulatory designation concentration kills Scarlet if EU or UK recognition is withdrawn.
  • Scarlet serves a tiny SaMD niche; customer concentration risks revenue volatility by 2026.
  • Competitors like RISE and traditional notified bodies can undercut Scarlet on trust.

What makes Scarlet unique

  • Scarlet NB B.V. is a 2023 EU MDR Notified Body for software.
  • Scarlet issued its first EU MDR certificate in November 2024.
  • Scarlet combines EU MDR, UK MDR, and ISO 13485 certification in one platform.

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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

0%

1 year growth

-1%

2 year growth

4%