Head of Regulatory Affairs / Quality Assurance (RA/QA) at Harrison AI

RA / QA, Full-time, Sydney sydney full-time
Description
Posted 25 days ago

About us
We're problem solvers, driven by a simple desire to do work that matters. We're constantly evolving ourselves and leveraging the latest AI technologies to create elegant, innovative solutions across the medical imaging sector.

annalise.ai is a global leader in applied medical AI and was formed through a unique partnership between harrison.ai and Australia's largest medical imaging service provider, I-MED Radiology Network. Leveraging our diverse and extensive medical imaging dataset, annalise.ai is developing tools to assist Radiologists by seamlessly integrating into their current workflow to provide diagnostic support. Our suite of comprehensive AI-solutions will support radiologists during their end-to-end process of imaging interpretation. 

About your role
Reporting to our Chief Operating Officer, we're looking for a seasoned Head of Global Regulatory Affairs and Quality Assurance (RAQA) to lead our regulatory affairs and quality assurance departments at Annalise.ai. This unique role has overall responsibility for the development, facilitation and execution of comprehensive regulatory strategies across the globe and throughout all phases of the product design and development cycle - ensuring successful medical device registrations in targeted jurisdictions. Additionally, your role will have direct oversight on our overall product quality through the maintenance of a comprehensive Quality Management System to ensure compliance with applicable regulatory requirements.

As Annalise.ai's growth plan is becoming more sophisticated through new product launches across worldwide target markets, we are in the midst of experiencing exciting challenges we have never had to solve before. With scale comes new problems to solve, and so you are not just thinking about what we need to do now to keep ahead of applicable regulatory changes and requirements - but also you are dreaming about what Annalise.ai will look like years from now and building strategic, scalable processes across the organisation that will enable us to get there.
 

What you'll do:

  • Lead and build an experienced team of RAQA professionals, providing advice and guidance on regulatory and quality policies/guidelines across the organisation; 
  • Establish and develop productive working relationship with regulators in Australia TGA, EU NB, US FDA and with other regulatory authorities as required;
  • Lead RA professionals to develop and/or approve regulatory strategy for planned products in targeted jurisdictions;
  • Oversee the establishment and maintenance of an ISO13485 compliant quality management system (QMS); 
  • Lead QA professionals and provide guidance on addressing product and process quality issues within the organisation;
  • Provide technical and expert advice on existing and emerging international regulations on AI and software driven medical devices;
  • Participate and represent the company in international workshops and forums on regulatory matters; and
  • Support your team in their personal and professional development, identifying training needs while keeping up to date with the dynamic global RAQA landscape and the latest developments in AI technology across the healthcare sector.
  • What will help you succeed:

  • Strong experience in a leadership role in the industry or with regulatory authorities in the field of Regulatory Affairs and Quality Assurance; 
  • In-depth knowledge and experience in at least one key regulatory jurisdiction (e.g. AU, EU, US); 
  • Proven experience in team management and leadership; and
  • Tertiary qualifications in a relevant field. 
  • Nice to have (but not essential):

  • In-depth knowledge and experience with multiple key regulatory jurisdictions, including but not limited to AU, EU and US - especially in relation to the regulation of software-as-medical-devices; 
  • Postgraduate degree in science/engineering/quality, preferably related to medical device, medical imaging, software or artificial intelligence; 
  • Sound knowledge and understanding of machine learning and deep learning principles; and 
  • Leadership experience in large enterprise organisations.
  • Why you'll enjoy working here:

  • Do work that matters - pioneering innovative and cutting edge AI technologies across the medical imaging sector to help make real, positive impact on patient outcomes around the world.
  • Flexible work - we value life at work and life outside of work. Plenty of flexible, part-time and remote work options available with us.
  • Expand your career with us – you'll be given a high degree of autonomy to make your mark in this role. In addition, we are big believers in lifelong learning and will support you to cross-skill in whichever direction you may choose to enhance your career.
  • Competitive remuneration – we know this isn't everything, but it's still an important consideration!
  • We're a scale-up with a unique culture - with inclusive social activities, wellbeing initiatives and collaborative team events (including virtual trivia, virtual cooking and live meditation sessions!), we celebrate achievements together and take care of our people.
  • What's next?

    Thank you for considering this opportunity with us! If this role is of interest to you, please apply now and we'll look forward to reviewing your application shortly.

    We are an ‘Equal Opportunity Employer’ and prohibit discrimination and harassment of any kind: we are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, age, colour, religion or belief, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.