QA Compliance and Governance Specialist (Sydney)

Big Picture is developing intelligent pathway technology, powering the first single platform for collaborative healthcare and clinical research globally. Our core solution captures structured, protocolised and clinically validated data, empowering better patient-centred outcomes and generating new leaps in healthcare.

Our teams collaborate across Sydney, London and remotely; servicing our customer base in Europe, Asia and North America. To achieve our mission, we drive Product-First frameworks. Fusing design, technology and clinical thinking together, we create simple software that clinicians deeply love to use.

The people who join us will have:

• An enthusiasm and readiness to make real change in the global healthcare and technology industry;
• The desire to work hard with a great team to solve life-changing, complex and challenging problems;
• Our inclusive values support genuine diversity in culture, experience and expertise;
• A hunger to build a vision from the ground up, while being proactive in identifying and filling gaps; and
• An attitude to make the whole team better because you are there.

The Role

As a QA Compliance and Governance Specialist, you will lead the process of achieving and maintaining relevant compliance and certifications for the Big Picture platform (e.g. CE, DCB, HIPAA, ISO 27001). You’ll also drive efforts on development and maintenance of our Quality Management Systems. At the same time, you’ll promote and influence a culture of quality across the entire business.

You will have 5 years+ experience managing internal and external teams to deliver QA, compliance and certification outcomes. You will also have experience with complex regulations and certifications over multiple jurisdictions. This will be accompanied by strong organisational and project management capabilities. 

In this role, you will ideally have experience with software as a medical device products, or cloud based technology platforms. If you don't, you have the confidence and initiative to pick up these skills quickly.

You'll work closely with the clinical, product and development teams to achieve gold standard clinical and regulatory requirements. You'll be able to manage yourself to deliver milestones, make significant decisions and lead the certification process for the Big Picture platform. 

A typical day for your new role might look like:

• Leading efforts on achieving relevant compliance and certifications (e.g. CE, DCB, DPP, PIA’s, Cybertrust, HIPAA, ISO 27001, etc);
• Ensuring compliance and certifications are continuously maintained to a best practice standard of quality and timing;
• Engaging with and coordinating third party contractors involved in QA, compliance, and  certification processes;
• Own the development and maintenance of our Quality Management Systems.

You’ll love this role if you:

• Thrive on working in a dynamic organisation that is rapidly evolving and are comfortable navigating through the ambiguity, change and occasional challenge that it creates;
• Have a growth mindset, a high ownership mentality and a willingness to take responsibility for goals and outcomes;
• Enjoy using your initiative and experience to identify (or ideally, preempt!) issues, while growing and supporting the team with new ways of thinking;
• Connect to our mission for better patient healthcare;
• Love the opportunity to oscillate between designing our overall compliance and governance framework across multiple jurisdictions but also genuinely enjoy delivering the tactical requirements with an unparalleled attention to detail on a day to day basis; and
• Are proud to deliver high-quality solutions.

If this sounds like you, please email people@bigpicturemedical.com to submit your application. Please include a cover letter along with your CV. We appreciate the time it takes to express your interest and are committed to responding to every application.