Regulatory Affairs Manager/Specialist

Franklin.ai aims to improve efficiency, affordability and quality in digital pathology using artificial intelligence solutions. Leveraging world leading AI technology, best engineering practices and a wealth of clinical expertise, Franklin.ai is building the next generation of technologies that will become standard clinical practice in pathology.

As the Regulatory Affairs Manager at Franklin.ai, you will have the unique opportunity to use your knowledge in regulatory science and your passion for technology to bring to market cutting-edge AI driven medical devices that positively impact patient lives at scale. Your role is to build and lead Franklin.ai’s regulatory affairs team to obtain regulatory clearances and to ensure regulatory compliance throughout the organisation. You will solve complex registration and compliance challenges for Software-as-Medical-Device (SaMD) and In-vitro diagnostic device (IVD) products. You will also have the opportunity to learn from a multi-disciplinary team that consists of domain experts in Artificial Intelligence, Clinical Research, Quality Assurance, Software Design & Development and Marketing.

What you'll be doing:

• Prepare and facilitate international regulatory submissions (Australia, US and other regions).
• Solve complex registration and compliance challenges with a focus on delivering favourable 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.

What we're looking for:

• Experience and knowledge in relation to either Australia, US or other major market’s medical device or IVD regulatory requirements and regulatory approval processes.
• Extensive experience in the submission and clearances of IVD software, SaMD or AI driven products.
• Be willing to learn and expand regulatory knowledge in other international jurisdictions.
• Have excellent interpersonal skills with the ability to influence and negotiate with key internal and external stakeholders to achieve favourable regulatory and business outcomes

Nice to have (but not essential):

• In-depth knowledge of IVD regulations – e.g. Australia TGA IVD regulations, EU IVDR or IVD regulations of other major jurisdictions.
• Experience building and leading an effective regulatory affairs team.
• Sound understanding of Machine learning/Deep learning principles.

Why join us?

💙 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.