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.
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.
Intro call with Aarzoo
Round 1: Team interviews: Interview with Steven and Johan (2x30 min)
Round 2: Founder interviews: Interview with James and Jamie (2x30 min)
Referencing
Offer
Skills Required
- 3+ years of experience supporting QMS implementation, audit preparation, or regulatory compliance activities
- Experience with EU MDR, UK MDR, MDSAP, and/or ISO 13485
- Experience teaching, designing training, or working with Learning Management Systems
- Exemplary verbal and written communication skills
What We Do
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
