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 roleAs Scarlet's first Market Access Operations hire, you will run projects to obtain new regulatory capabilities for Scarlet from governments and accreditation bodies. You will own projects from initial idea through to delivering the first certificates to customers. You will use market research, project management and commercial work to identify and obtain new approvals. You will find the first customers, issue the first certificate and turn what we learn into repeatable workflows. Your work will give our customers access to new markets and make medical devices available to more patients that need them sooner.
ResponsibilitiesResearch new markets, regulatory approvals and certifications, assess their potential value to customers and make prioritisation decisions on how to sequence them.
Lead new approval applications from start to finish. Coordinate Scarlet teams, external experts and regulatory bodies, resolve blockers and keep several applications moving at once.
Identify manufacturers who need new approvals, close deals with the first customers and coordinate their journey through a service Scarlet is delivering for the first time.
Build repeatable processes, tooling and knowledge so that each new approval makes the next one easier.
Hand new approvals to the teams that will run them at scale, including the documentation, decisions and regulatory relationships needed for delivery.
At least three years’ experience in a commercial, strategy or business operations role, ideally in a start-up or other fast-moving environment.
Experience leading complex, multi-part projects from initial idea through delivery, involving internal and external teams
Experience evaluating opportunities from strategic and commercial perspectives and making clear recommendations
Experience researching unfamiliar systems, synthesising incomplete information, analysing data and turning findings into concrete plans
Experience building or improving operational processes and tooling so that repeated work becomes faster
Experience writing concisely and communicating complicated topics clearly.
Intro call with Tiri and/or Nadine — 30 mins
Team interview with Emily — 45 mins
Problem-solving interview with Tiri and/or Nadine — 45 mins
Culture and values interviews with James and Jamie — 2 × 30 mins
Skills Required
- 3+ years experience in a commercial, strategy or business operations role
- Experience in a start-up or other fast-moving environment
- Relentless drive to create momentum and unblock problems
- Operational excellence and experience turning manual processes into repeatable systems
- Commercial judgement to evaluate opportunities and trade-offs
- Analytical problem solving and ability to synthesise incomplete data
- Exceptional written and verbal communication
- Experience in healthcare, medical devices, or another regulated industry
- Experience conducting market research or evaluating new markets and commercial opportunities
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
