Regulatory Affairs Specialist

**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.
- ** Act as a key liaison**: Manage day-to-day interactions with UK and EU Notified Bodies, Competent Authorities, and external regulatory consultants.

**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?**
- We create unconventional solutions to difficult problems and we build them fast. We want you to set impossible goals and make them happen, think landing a rocket but the medical version.
- You'll be surrounded by a world-class team of data governance professionals, engineers, medicos and designers to do your best work, inspired by our shared beliefs:

- We will stop at nothing to improve patient care across the world.
- We design user experiences for joy and ship them fast.
- We make decisions in a flat hierarchy that prioritizes the truth over rank.
- We provide the resources for people to succeed and give them the freedom to do it.

**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 reima