ABOUT HEIDI

Heidi is on a mission to halve the time it takes to deliver world-class care.
We believe that by 2050, every clinician will practice with AI systems that free them from administrative burdens and increase the quality and accessibility of care to patients across the world.
Built for clinicians, by clinicians, at the core of Heidi is its people. We are an eclectic bunch of inventors, builders, scientists, nurses, doctors, mathematicians, designers, creatives, and high-agency executors.
We achieve in 6 months what it takes our competitors 4 years to do. In just 12 months, 20 million patient consults were supported by Heidi, and we’re now powering more than 1 million consults every week.
With our most recent $16.6MM round of funding from leading VC firms, we’re geared up to supercharge our ambitious global growth, starting with the US, Canada, UK and Europe - and we need great people like you to get there. Ready for the challenge?

THE ROLE

As our Regulatory Affairs Specialist, you’ll play a crucial role in navigating the complex and evolving regulatory landscapes for medical devices, impacting our ability to deliver world-class care to patients across the UK and Europe.
If you’re an ambitious and proactive problem-solver with a strong background in regulatory affairs and a desire to make a real difference in healthcare, we want to hear from you!

WHAT YOU’LL DO:

• Drive regulatory strategy: Develop and implement quality and regulatory strategies for product development and commercialisation in the UK and EU.
• Lead conformity planning: Manage the company’s medical device readiness, taking a lead role in detailed MDR and UKCA conformity planning and execution.
• Be a regulatory champion: Provide proactive regulatory guidance to cross-functional teams (Product, Clinical, Marketing) throughout the product lifecycle.
• Oversee technical documentation: Manage the development, compilation, and maintenance of UK/EU technical files, coordinating with internal teams and stakeholders.
• Manage post-market activities: Take the lead on establishing and managing Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
• Ensure quality: Drive the continuous improvement and maintenance of our Quality Management System (QMS) to ensure compliance.
• Navigate emerging tech regulations: Act as a key resource on the EU AI Act, working with subject matter experts to interpret and implement AI governance obligations.
• Act as a key liaison: Manage day-to-day interactions with UK and EU Notified Bodies, Competent Authorities, and external regulatory consultants.
• Own regulatory submissions: Prepare and manage regulatory filings and applications, taking ownership of the submission process under the guidance of the Head of Legal and Regulatory Affairs.