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As a Clinical Evalutation Specialist, at Harrison.ai, you will play a vital role supporting the clinical evaluation of software as medical device (SaMD) artificial intelligence (AI) products used in diagnostic medical imaging. This role is an exciting opportunity for a highly motivated individual to join a uniquely talented Medical Affairs team, who’s primary department focus is to conduct clinical studies in accordance with applicable standards and regulations, and generate high quality clinical documentation supporting the regulatory, commercial and marketing strategy for Harrison.ai products.

Reporting to the Director, you will be responsible for the planning and generation of a wide range of documentation supporting the evaluation of Harrison.ai SAMD, including state of the art literature reviews, clinical evaluation plans and reports, and other post-market documentation to support regulatory submissions. You will also have opportunity to contribute to the dissemination of claims and publication of clinical evidence for Harrison.ai devices. This role will see you coordinate interactions between a range of internal and/or external stakeholders and Subject Matter Experts (SMEs), so you will need strong written and verbal communication skills.

You will have experience writing clinical documents in accordance with applicable standards and regulations within a medical device setting. As we pioneer new ways of improving health delivery at scale using the most cutting-edge AI technologies, we invite you to consider an exciting, meaningful role with the Clinical Research and Medical Affairs team here at Harrison.ai.

• Develop and maintain scientific knowledge in the state of the art for AI-based radiology SaMD by conducting systematic literature reviews and surveying the competitor landscape.

• Assist with the development and maintenance of clinical evaluation plans and reports, and other relevant post-market documentation supporting the regulatory submissions for SaMD.

• Assist with the evaluation of Harrison.ai medical devices through review of product intended use, state of the art and pre-market / post-market clinical evidence.

• Establish and maintain a clinical evidence and claims database.

• Review and appraise clinical evidence to substantiate clinical claims for product marketing.

• Contribute to the evidence dissemination strategy by preparing conference abstracts and/or high-quality manuscripts for peer-reviewed publication.

• Effectively manage liaisons between internal and external stakeholders from cross-functional teams.

• Perform quality assurance and manage document reviews, ensuring all documents are well organized, scientifically accurate, consistent, and in compliance with applicable Standard Operating Procedures (SOPs), guidelines and regulations.

• Assist with the development of work tools, systems, SOPs or work instructions to support the delivery of projects within the clinical research and medical affairs team.

• Complete documents within a period that supports the product roadmap and deadlines.

• Bachelor’s degree in a scientific or related field (e.g., medical sciences, pharmacology, engineering).

• 3-5 years of experience in clinical research, medical or regulatory affairs or a related function within the pharmaceutical, biotechnology, or medical device industry.

• Proficiency in conducting systematic and efficient literature searches to identify relevant scientific and technical literature.

• Familiarity with clinical evaluation processes and other regulatory compliance requirements in major markets (EU, US and Australian Medical Device Regulations). Including experience preparing and writing clinical evaluation reports and clinical evaluation plans independently.

• Ability to comprehend, critique, analyse and synthesise large amounts of scientific and clinical data.

• Excellent oral communication and technical writing skills.

• Able to work independently as well as collaborate within a larger team.

• Strong interpersonal skills and experience managing stakeholders from cross-functional teams.

• Detail-oriented, organised with the ability to manage multiple projects simultaneously.

Nice to have skills and characteristics:

• Masters/PhD or post-graduate qualification in a relevant area of medical science.

• Experience working in research involving artificial intelligence, SaMD, radiology or related medical imaging field.

• Knowledge of Good Clinical Practice or other harmonised standards.

• Established publication record.

At Harrison.ai, we’re redefining what’s possible in healthcare. Through our diagnostic AI solution, we’re building AI tools that help clinicians deliver earlier, more accurate diagnoses and raise the standard of care for millions of patients worldwide.

Our mission is bold but simple: to scale global healthcare capacity and create a fairer, healthier world. By using AI as a co-pilot for clinicians, we’re tackling one of healthcare’s biggest challenges, the shortage of human expertise, and giving every patient the chance to access timely, high-quality care, no matter where they live.

Because while we’re building cutting-edge AI, what we’re really building is hope—that everyone can access the healthcare they deserve.

And we’re just getting started.

If you’re inspired by what we're up to, please apply now and we'll be in touch soon.

We are proud to be an Equal Opportunity Employer. Diversity’s not a buzzword here, it’s in our DNA. Diverse perspectives shape our culture and make our work better. We’re committed to building inclusive teams that represent a variety of backgrounds and skills. We look forward to hearing from you.