(3 Days Left) Regulatory Affairs Specialist

About Heidi

Heidi is building an AI Care Partner that supports clinicians every step of the way, from documentation to delivery of care.

We exist to double healthcare’s capacity while keeping care deeply human. In 18 months, Heidi has returned more than 18 million hours to clinicians and supported over 73 million patient visits. Today, more than two million patient visits each week are powered by Heidi across 116 countries and over 110 languages.

Founded by clinicians, Heidi brings together clinicians, engineers, designers, scientists, creatives, and mathematicians, working with a shared purpose: to strengthen the human connection at the heart of healthcare.

Backed by nearly $100 million in total funding, Heidi is expanding across the USA, UK, Canada, and Europe, partnering with major health systems including the NHS, Beth Israel Lahey Health, MaineGeneral, and Monash Health, among others.

We move quickly where it matters and stay grounded in what’s proven, shaping healthcare’s next era. 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.

What we will look for:

- 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices and ideally covering data governance, privacy, and emerging technology regulations like the EU AI Act.

- A strong ambition and readiness to lead projects and make a significant impact in a high-growth environment.

- A strong working knowledge of EU MDR 2017/745 and UKCA marking requirements, with familiarity with the emerging EU AI Act being a significant plus.

- Direct experience compiling technical documentation and managing PMS/PMCF activities, with a solid understanding of relevant ISO standards.

- A proactive and detail-oriented mindset, with a commitment to quality and the ability to drive tasks to completion.

- Excellent communication and collaboration skills, enabling you to work effectively with internal teams and manage external partners.

- A Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline.

- A passion for quality and a relentless drive to improve healthcare. You're an investigative mind with strong analytical and problem-solving skills.

- Fluency in English is required and proficiency in at least one other major European language is a benefit.

What do we believe in?

Heidi builds for the future of healthcare, not just the next quarter, and our goals are ambitious because the world’s health demands it. We believe in progress built through precision, pace, and ownership.

- Live Forever - Every release moves care forward: measured, safe, and built to last. Data guides us, but patients define the truth that matters.

- Practice Ownership - Decisions follow logic and proof, not hierarchy. Exceptional care demands exceptional standards in our work, our thinking, and our character.

- Small Cuts Heal Faster - Stability earns trust, speed delivers impact. Progress is about learning fast without breaking what people depend on.

- Make others better - Feedback is direct, kindness is constant, and excellence lifts everyone. Our success is measured by collective growth, not individual output.

Our mission is clear: expand the world’s capacity to care, and do it without losing the humanity that makes care worth delivering.

Why you will flourish with us

- Flexible hybrid working environment, with 3 days in the office.

- Additional paid day off for your birthday and wellness days

- Learn from some of the best engineers and creatives, joining a diverse team

- Become an owner, with shares (equity) in the company, if Heidi wins, we all win

- The rare chance to create a global impact as you immerse yourself in one of Australia’s leading healthtech startups

- If you have an impact quickly, the opportunity to fast track your startup career

- Help us reimagine primary care and change the face of healthcare in Australia and then around the world

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