Market Access Operations

We pull medical technology from the future to solve human health.   Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar. Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale. ABOUT THE ROLE: Scarlet specialises in helping Software and AI Medical Devices get to the people who need them. Until now, that was purely standalone software. However, the next wave of innovation is physical medical devices that incorporate Software and AI. To serve these cutting-edge devices, Scarlet needs to gain new regulatory approvals. We also know that Medical Device Manufacturers need more than just the bare minimum regulatory approvals to get to market. Increasingly, certifications like ISO/IEC 27001 and ISO/IEC 42001 are required in the procurement processes that enable these devices to have a real impact. To ensure a smooth journey to market, Scarlet needs to gain new regulatory approvals. Finally, we know that the UK, the EU and the USA aren’t the only markets in the world. All our manufacturers have global ambitions, and all markets have their own regulatory paths to market. To facilitate global access, Scarlet needs to gain new regulatory approvals. You get the gist. To serve our mission and get cutting-edge technology to the people who need it, we still need many more regulatory approvals. This role will own, operate and iterate on the systems to go after a conveyor belt of approvals - the market research, the project management for new applications, and finding, closing and coordinating the first-ever customers for new approvals. WHO YOU ARE: - Experience: You have 3+ years of experience, ideally in a start-up or other fast-moving environment, in a commercial, strategy or business operations role. - Drive: You are relentless about creating momentum. You follow up, unblock problems and find another route when the obvious one isn't working. You're comfortable pushing complex projects forward through competing priorities and inevitable setbacks, and you don't need external urgency to create your own. - Operational excellence: You have high standards and care deeply about the quality of your work. You’re constantly looking for ways to turn messy, manual processes into efficient, repeatable systems, so that the next project is faster and better than the last. - Commercial judgement: You can analyse an opportunity from both a strategic and commercial perspective. You're comfortable assessing whether an approval is worth pursuing, what it will take to achieve, and how to balance that against other opportunities. - Analytical problem solving: You approach unfamiliar problems from first principles. You can find and synthesise information from messy or incomplete sources, interrogate data, and use evidence and logic to reach clear conclusions. - Communication: You're an exceptional written and verbal communicator. WHAT THE JOB INVOLVES: You’ll own Scarlet’s expansion into new regulatory approvals, certifications and markets from initial idea through to the first customers successfully using them. That means: - Finding the next opportunity: Research new markets, regulatory approvals and certifications that could unlock value for Scarlet’s customers. Build a view of the opportunity, understand the requirements and make a recommendation on where Scarlet should invest its time. - Figuring out how to get there: Turn unfamiliar regulatory systems into a concrete plan. Work with Scarlet’s regulatory teams to determine what Scarlet needs to build, change or demonstrate to achieve a new approval, who needs to be involved, and what the critical path looks like. - Driving approvals over the line: Own new applications end-to-end. Coordinate with internal teams, external experts and regulatory bodies; keep track of hundreds of details; anticipate blockers; and relentlessly drive multiple projects forward until the approvals are secured. - Finding the first customers: Identify manufacturers who need the new approvals, close the deals with the first customers, and coordinate their journey through a service Scarlet is delivering for the very first time. - Building the machine: Each new approval should make the next one easier. Build the processes, tooling and knowledge that turn one-off projects into a repeatable system for launching new regulatory capabilities. - Owning the outcome: These projects won't fit neatly within one function. You'll work across commercial, regulatory, product and people functions, stepping into whatever gaps exist to keep up momentum. - Crystal clear handovers: Once we gain approvals, you will hand over the responsibility to deploy these approvals at scale to several teams. Through top-notch communication, you’ll ensure the context is available and the regulatory relationships are set up for success. INTERVIEW PROCESS: - 30 min Intro call - Tiri https://www.linkedin.com/in/tirion-h-evans/ and/or Nadine https://www.linkedin.com/in/nadinecaballero/ - 45 min Team Interview - Emily https://www.linkedin.com/in/emilyotterbeck/ - 45 min Problem Solving Interview - Tiri https://www.linkedin.com/in/tirion-h-evans/ and/or Nadine https://www.linkedin.com/in/nadinecaballero/ - 30 mins Culture Interview - James https://www.linkedin.com/in/james-dewar-78758992/ - 30 mins Culture Interview - Jamie https://www.linkedin.com/in/jamie-cox-01458b3a/