Regulatory Education Specialist (Quality)

Overview

Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet.

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.

Responsibilities

- 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.

Required Skills

- 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.
- Understanding of what makes a high-quality QMS and what it takes to prepare companies for audits.
- Experience teaching, designing training, or working with Learning Management Systems.
- Exemplary verbal and written communication skills, aligned with MECE principles and adapted to an asynchronous work environment.

Benefits

- Offers Equity

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About the company

Scarlet

Software and AI are the future of medicine. We're helping to pull the future into today with a specialised certification process for SaMD manufacturers. This means you can safely, predictably, and continuously get the best technology to market.

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