Key Facts

Remote From:

Europe , European Union

Category: Regulatory Analyst

Full time

Mid-level (2-5 years)

English

Hard Skills

Instructional Design ISO 13485 Standard Total Quality Management Lesson Planning Regulatory Compliance Learning Management Systems Training Documentation Regulatory Compliance Database Diagram Video Production +8 more

Other Skills

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Discussion Facilitation
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Non-Verbal Communication
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Collaboration
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Dynamic Communication

Roles & Responsibilities

3+ years of experience supporting Quality Management System (QMS) implementation, audit preparation, or regulatory compliance activities under EU MDR, UK MDR, MDSAP, or ISO 13485
Strong understanding of what makes a high-quality QMS and experience preparing companies for audits
Experience teaching, designing training, or working with Learning Management Systems
Excellent verbal and written communication skills, MECE-aligned and adaptable to asynchronous work

Requirements:

Create high-quality content enabling medical device innovators to understand the QMS and audit requirements of EU MDR, UK MDR, MDSAP, 510(k), ISO 13485 and others
Design education-grade materials, including slides, diagrams, lesson plans, and voiceover scripts, for use across videos, knowledge base articles, and enablement tools
Lead structured dialogues that clarify core concepts, surface common pitfalls, and align medical device innovators on what 'good' looks like
Work closely with auditors to ensure that published materials reflect a consistent, aligned regulatory view

Scarlet

About Scarlet

Scarlet certifies software medical devices. We are Europe’s only Notified Body specialised in Software & AI. Our mission is to hasten the transition to accessible, affordable healthcare. We strive to achieve our mission by enabling our customers to deliver on theirs, and get their life-changing technology to the people who need it. Scarlet was built specifically for software and AI medical devices. We help customers to get their SaMD certified in the EU & UK, and ship the kind of regular updates inherent to good software, ensuring patients can safely get the most up-to-date technology.    Scarlet is designated as an EU Notified Body under regulation (EU) 2017/745 (EU MDR). And a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended). Scarlet is also accredited to issue ISO 13485 certificates.

Company type: Scaleup

Founded: 2018

Company size: 11 - 50

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Job description

Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our groundbreaking approach enables the most innovative technology to reach patients safely and quickly.

Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet. We are proud to count the world’s best resourced and most ambitious companies building medical AI as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.

Come help us bring the next generation of healthcare to the people who need it.

Who you are:

You have 3+ years of experience supporting Quality Management System (QMS) implementation, audit preparation, or regulatory compliance activities under EU MDR, UK MDR, MDSAP, and/or ISO 13485.
You understand what makes a high-quality QMS and what it takes to prepare companies for audits.
You have experience teaching, designing training, or working with Learning Management Systems.
You’re motivated by the opportunity to shape how high-quality regulatory and quality documentation is taught, learned, and standardised at scale.
Your verbal and written communication skills are exemplary, aligned with MECE principles and adapted to an asynchronous work environment.

What the job involves:

Create high-quality content that enables medical device innovators to understand the QMS and audit requirements of EU MDR, UK MDR, MDSAP, 510(k), ISO 13485 and others.
Design education-grade materials, including slides, diagrams, lesson plans, and voiceover scripts, for use across videos, knowledge base articles, and enablement tools.
Lead structured dialogues that clarify core concepts, surface common pitfalls, and align medical device innovators on what “good” looks like.
Work closely with the auditors to ensure that everything we publish reflects a consistent, aligned regulatory view.