Market Access Operations

1 нед. назад

60k–70k GBP / yearUnited KingdomEuropeOnsite

iso 27001iso 42001regulatory compliance

Coordinate and manage regulatory approvals and certifications for medical AI and physical medical devices to ensure global market access.

Обязанности

specialises 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, 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, 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.
You’ll own ’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 ’s customers. Build a view of the opportunity, understand the requirements and make a recommendation on where should invest its time.
Figuring out how to get there : Turn unfamiliar regulatory systems into a concrete plan. Work with ’s regulatory teams to determine what 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 : Work with 's commercial teams to identify manufacturers who need the new approval, help win the first customers, and coordinate their journey through a service 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 get from "we should be able to do this" to a capability can confidently sell and deliver.
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.

Требования

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.

Как откликнуться

30 min Intro call - Tiri and/or Nadine
45 min Team Interview - Emily
45 min Problem Solving Interview - Tiri and/or Nadine
30 mins Culture Interview - James
30 mins Culture Interview - Jamie

Другое

Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.
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.
Experience in healthcare, medical devices, or another regulated industry.
Experience conducting market research or evaluating new markets and commercial opportunities.