Senior Regulatory Affairs Manager

Sydney /
RA/QA /
Full-time
/ Remote
As part of the Regulatory Affairs & Quality Assurance team, you’ll help ensure the high quality of our products, and that they comply with government regulations.

About us: franklin.ai
 
franklin.ai aims to apply the latest methodologies in artificial intelligence (AI) to ultimately put groundbreaking AI tools in the hands of pathologists.
 
franklin.ai is a joint venture between global medical diagnostic leader Sonic Healthcare (ASX:SHL) and health technology game-changer harrison.ai with a mission to raise the standard of healthcare for millions of patients every day.
 
Globally, pathology faces a stark skills shortage, with the number of US pathologists decreasing 18% between 2007 and 2017 despite an increase in workload. Building comprehensive AI solutions for pathology will help scale the capacity of diagnostic care across the globe. This new partnership combines harrison.ai's depth of expertise and comprehensive AI methodologies with Sonic Healthcare's global clinical experience and distribution. The collaboration will unlock digital pathology to provide pathologists with a second set of eyes, using state-of-the-art AI technology to deliver efficient and accurate diagnosis support.
 
We’re redefining what’s possible in healthcare, through AI technology.

About your role:

As the Regulatory Affairs Manager at Franklin-AI, you will have the unique opportunity to bring cutting-edge AI driven medical devices that positively impact patient lives at scale to market . 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 do:

    • Prepare and facilitate international regulatory submissions (Australia, UK, EU 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. 
    • Build and lead an effective regulatory affairs team.

What we're looking for:

    • Experience in Australian, EU or other major market’s medical device or IVD regulatory requirements and regulatory approval processes.  
    • A willingness to learn and expand regulatory knowledge in other international jurisdictions.  
    • 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:

    • Extensive experience in the submission and clearances of IVD software, SaMD or AI driven products.  
    • 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: our pioneering Pathology AI solutions will help detect cancer, improve diagnostic accuracy and potentially save millions of lives.
💻 Flexible working: we have a remote-first environment with a cool office for social events and brainstorming sessions, or even full-time onsite if you prefer.
🌱 Grow your career with us: we are believers in lifelong learning. You’ll have access to a variety of resources and continuous career development opportunities.
👉 Competitive salary and equity: we’re constantly analysing market rates to keep our compensation up to date, in addition to offering a generous stock options program.
🚀Stay at the top of your game: work with diverse teams of industry experts and leaders who are passionate about what they do.
🙌 Vibrant culture: with sponsored team activities, fun social events and a supportive work environment, your holistic wellbeing is top of mind.

What’s next?
 
Thank you for considering becoming part of our team. Please apply now to register your interest and we look forward to reviewing your application shortly.
 
We are proud to be an Equal Opportunity Employer. We celebrate diversity and we are committed to building inclusive teams that represent a variety of backgrounds, perspectives and skills. The more inclusive we are, the better our work will be. All employment is decided on the basis of qualifications, merit and business need. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage of our hiring process, you may contact us at careers@franklin.ai