What we’re about

At Harrison.ai, we’re redefining what’s possible in healthcare. Through our diagnostic AI solutions, we’re building tools that support clinicians to deliver earlier, more accurate diagnoses and raise the standard of care for millions of patients worldwide.

Our mission is bold but simple: to scale global healthcare capacity and create a fairer, healthier world. By using AI as a co-pilot for clinicians, we’re tackling one of healthcare’s biggest challenges, the shortage of human expertise, and giving every patient the chance to access timely, high-quality care, no matter where they live.

Because while we’re building cutting-edge AI, what we’re really building is hope—that everyone can access the healthcare they deserve.

And we’re just getting started.

About Your Role

The Regulatory Affairs Specialist is responsible for providing regulatory expertise throughout the product lifecycle to maintain regulatory compliance. You will help solve complex compliance challenges for Software-as-Medical-Device (SaMD) products. You will also have the opportunity to progress your career by learning from a multi-disciplinary team that consists of domain experts in Machine learning/Artificial Intelligence and Software Design & Development.

This is a rare opportunity to make both a regulatory and clinical impact — all within a collaborative environment that values innovation, agility, and purpose. You’ll be part of a team passionate about advancing cutting-edge technologies in the medical device field, including medical software, AI, and machine learning, while continuously expanding your regulatory knowledge across international jurisdictions.

What You'll Do:

• Creation and maintenance of Technical Files

• Compilation of regulatory dispatches in accordance with global requirements and management of regulatory submissions to achieve successful regulatory approval

• Collaborate with internal stakeholders to prepare and submit responses to questions from regulatory authorities and notified bodies

• Liaise with authorised representatives and regulatory authorities

• Solve complex registration and compliance challenges with a focus on delivering business results through collaboration, accountability and innovation

• Assess the regulatory impact of new products/product changes to facilitate the timely commercialisation of new or modified products in global markets

• Review product labelling and promotional material for regulatory compliance

• Provide ongoing regulatory advice to project teams to ensure regulatory requirements are met

• Vigilance reporting/recall notification with regulators and/or country representatives

• Comply with all company policies, procedures and guidelines including those relating to information security

• Keep up to date on new and evolving regulatory intelligence

What You'll Bring:

• Degree in software, engineering, science or related discipline

• Minimum 2 years’ experience in a Medical Device Regulatory Affairs role.

• Sound understanding of global medical device registration processes, especially TGA and EU MDR

• Excellent attention to detail and ability to multi-task and balance competing priorities.

• Ability to build relationships between Regulatory Affairs and other areas of the business to work adhesively at all levels.

• Ability to work autonomously

Nice to have skills and characteristics:

• Experience in medical device software

Why join us?

🌍 Innovate for Global Good. Join us to pioneer world-first AI technology that transforms patient outcomes and helps build a healthier, fairer world.

🤝 Collaboration Across Continents. Work with brilliant minds from every corner of the globe in a culture built on trust, autonomy, and genuine teamwork.

🚀 Well-Funded & Global. Backed by world-class investors including Aware Super, Blackbird Ventures, Skip Capital, and Horizons Ventures, we’ve raised over US$240M to accelerate our global impact.

🌱 Scale Your Potential. Tap into yearly L&D budgets, mentoring, hackathons, and secondments—all supported by a transparent growth framework to grow your career.

💻Flex for Life. Work when and where you do your best—with WFH options, flexible hours, and the autonomy to make an impact your way.

🙌 Support for Every Family Journey. From fertility to parenthood, loss, and even grandparenthood—we provide inclusive, thoughtful policies to support families in every stage.

What's next?

If you’re inspired by what we're up to, please apply now and we'll be in touch soon.

We are proud to be an Equal Opportunity Employer. Diversity’s not a buzzword here, it’s in our DNA. Diverse perspectives shape our culture and make our work better. We’re committed to building inclusive teams that represent a variety of backgrounds and skills. We look forward to hearing from you.