Product Manager

Company Description

Akunah is a pioneering Software as a Medical Device, AI and data analytics company at the forefront of personalised healthcare software solutions. With a global presence, our mission revolves around empowering equitable and evidence-based healthcare solutions. Our core operations include complex and revision surgical case planning, a cloud-based platform for optimizing patient engagement and clinical workflows, and cutting-edge artificial intelligence driving our efficient healthcare solutions. With a commitment to innovation, Akunah is making significant strides in healthcare transformation.

Role Description

We are seeking a highly motivated and experienced Product Manager – Software as a Medical Device (SaMD) to lead the development and lifecycle management of our medical device software products. You will be responsible for driving the design, development, and product lifecycle activities of regulated software products designed to meet clinical needs and regulatory requirements, ensuring they deliver real value to patients and clinicians.

As the SaMD Product Manager, you will work closely with cross-functional teams including IT, quality, regulatory, clinical, and engineering to deliver innovative, safe, and effective software solutions that comply with global medical device regulations.

Key Responsibilities:

• Collaborate with internal and external stakeholders to gather user needs and translate them into actionable software specification requirements.
• Manage software development activities while ensuring compliance to the company's Quality Management System and relevant regulatory standards for SaMD.
• Sprint management and backlog prioritisation to ensure alignment across development, QA, and delivery to ensure business objectives are met.
• Ability to plan and conduct product and feature testing for verification and validation activities.
• Write and maintain technical documentation to comply with relevant regulatory (e.g, FDA, TGA) and quality standards (ISO 13485, IEC 62304, ISO
• Partner with regulatory and quality teams to support regulatory submissions and audits.
• Coordinate product development lifecycle activities, from concept through to post-market surveillance and product maintenance, ensuring continuous improvement and compliance.
• Collaborate with sales team for customer onboarding and collecting user feedback to inform enhancements and future development.
• Represent the product in conferences, stakeholder meetings, partner collaborations, and customer sessions.

Qualifications:

Required:

• Bachelor's degree in Medical Engineering, Computer Science, or a related field.
• 3+ years of product management experience in the medical device or healthcare technology industry.

• Proven experience with Software as a Medical Device (SaMD), including familiarity with standards such as ISO 13485, IEC 62304, and ISO 14971 and demonstrated ability to apply risk-based approach to the decision-making process.

• Familiarity with Agile software product development methodologies.

• Experience with Atlassian Suite (Jira, Confluence, Bitbucket) or similar product management tools.
• Demonstrated experience working with cross-functional teams in a regulated environment.
• Excellent communication, collaboration, and organizational skills.

Preferred:

·       Familiarity with 3D modelling, registration techniques, or robotics applications

·       Comfortable with IT infrastructure and technical concepts such as REST APIs and integration with 3
rd
 party services.

Must have appropriate working visa. This role will be onsite in Brisbane, Australia.