Regulatory Affairs Manager

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• Do work that matters. We're pioneering AI technologies that help raise the standard of healthcare for millions of people every day.
• Well-funded and global, backed by world-class investors including Aware Super, Blackbird Ventures, Skip Capital, and Horizons Ventures. Harrison.ai's total capital raised to date exceeds US$240 million.
• Work with a bunch of awesome, genuine people who are passionate about what they do.
• Flexible and remote-friendly working
• Make a real impact. You won't be another 'cog in the wheel' here. We give full trust and autonomy for you to be heard, to work on the big hairy projects – and to make a real difference.
• Grow your career with us. We're big believers in lifelong learning. You'll be given a $1000 personal L&D budget, plus opportunities for internal mobility to grow your career.
• Market-leading parental support including 16 weeks gender-neutral paid parental leave and $10,000 support for egg or sperm freezing.

Franklin.ai is committed to impacting lives and health outcomes globally by improving access to quality pathology services. We aim to enhance efficiency, affordability, and quality in digital pathology using AI solutions. Leveraging world-leading AI technology, engineering practices, and clinical expertise, Franklin.ai is building the next generation of technologies that will become standard in pathology.

As the Regulatory Affairs Manager at Franklin.ai, you will use your regulatory science knowledge and passion for technology to bring cutting-edge AI-driven medical devices to market, positively impacting patient lives at scale. Your role involves building and leading Franklin.ai's regulatory affairs team to obtain regulatory clearances and ensure compliance throughout the organization. You will solve complex registration and compliance challenges for Software-as-Medical-Device (SaMD) and In-vitro diagnostic device (IVD) products, and collaborate with a multidisciplinary team of domain experts.

• Prepare and facilitate international regulatory submissions (Australia, US, and other regions).
• Solve complex registration and compliance challenges with a focus on delivering favorable regulatory and business outcomes.
• Work within a multi-disciplinary team to ensure regulatory requirements are fulfilled.
• Establish and maintain medical device/IVD technical files.
• Facilitate adverse event reporting and field actions when required.
• Review advertising material to ensure regulatory compliance.

• Experience and knowledge of medical device or IVD regulatory requirements and approval processes in Australia, US, or other major markets.
• Willingness to learn and expand regulatory knowledge in other international jurisdictions.
• Excellent interpersonal skills to influence and negotiate with stakeholders for favorable outcomes.

• Extensive experience in submission and clearance of IVD software, SaMD, or AI-driven products.
• In-depth knowledge of IVD regulations (e.g., Australia TGA IVD regulations, EU IVDR).
• Experience building and leading regulatory teams.
• Understanding of Machine Learning/Deep Learning principles.

We're redefining healthcare through AI technology, aiming to scale global healthcare capacity and elevate clinician care. Since 2019, Harrison.ai has rapidly grown to 200+ employees worldwide, raising over US$240 million. Our AI software has impacted lives through IVF, medical image diagnosis, and early cancer detection in pathology. We're just getting started—join us to shape the future of AI in healthcare and make a real difference in lives.

If inspired, please apply now. We are proud to be an Equal Opportunity Employer, valuing diversity and inclusion in our teams.