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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. About the role: We’re at an influential point in regulatory history for healthcare - and we’re looking for someone to help shape it. At a time when the regulatory environment across both the EU and the UK are in a state of flux, it’s more important than ever that policy officials and regulators are making informed decisions. We’re not short of experts who have a deep understanding of safe and performant medical software. Which means that we’re opinionated on how regulatory requirements and guidance should be designed and implemented to ensure that that software gets into the hands of the people who need it quickly. This role is about delivering the right message to the right people at the right time.
Job Responsibility:
Proactively monitor policy and regulatory developments and communicate those developments to the relevant people internally
Manage Scarlet’s advocacy on regulatory change - including “holding the pen” on submissions, coordinating the relevant internal experts, ensuring quality and consistency across jurisdictions and subject areas, and managing submission timelines
Build and maintain relationships with policy officials, legislative drafters, and regulators across the EU and the UK
Own and grow our “no surprises” policy by identifying opportunities to keep our regulators and policy officials informed of updates to Scarlet’s business, processes, and tooling
Develop a deep understanding of the legislative and standards drafting process, the relevant stakeholders, and the key areas for influence
Manage coordination with other regulatory stakeholders (e.g. Team AB, NBCG-Med etc.)
Lead regulatory relationships as Scarlet expands into new jurisdictions (e.g. US / APAC)
Requirements:
5-10 years experience working within a heavily regulated environment - ideally in a government relations, public affairs or communications role
Strong interpersonal skills and the confidence to proactively voice positions and obtain meetings with key stakeholders
Experience with UK or EU institutions and legislative processes
Exceptional written and verbal communication and advocacy skills
Ability to quickly upskill in and understand new technologies
Nice to have:
In-depth knowledge of medical device regulations
Existing relationships within EU and/or UK political / regulatory institutions