Get AI-powered advice on this job and more exclusive features.This range is provided by Rosewood Partners.
Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay rangeA$130,000.00/yr - A$160,000.00/yrManaging Partner at Rosewood Partners - Product | eCommerce | Engineering | TechAbout the CompanyThis groundbreaking AI Software as a Medical Device (SaMD) startup is committed to transforming clinical care decision-making and improving patient outcomes globally through state-of-the-art software technologies.
The company has already secured regulatory approval and early commercialisation in markets across the globe, and is preparing for FDA clearance and US market entry for their first product.This is an opportunity to enter as the company begins to scale.
They are backed by a significant investment partnership and are rapidly accelerating their growth trajectory, so there is potential for you to have huge influence on the success of the company, with plenty of opportunities for personal growth.As our client is preparing for targeted market entry and global market expansion, they are seeking a highly capable, SaMD Product Owner to support the VP of Product.
The Product Owner will support all work streams pertaining to development, release, and in-market management of SaMD products across global markets.This opportunity offers unparalleled exposure to new business building at the intersection of artificial intelligence and healthcare in collaboration with world-class experts from healthcare provider networks, academia, and industry.ResponsibilitiesOversee SaMD planning and release processes and documentationWork hand-in-hand with the engineering team to facilitate product development sprints, including feature definition, effort sizing, conducting retrospectives, and contributing to product roadmapsManage the overarching system of SaMD documentation (e.g., product requirements, specifications, risks, mitigations) across products, versions, and regions in response to customer feedback and audit outcomesOwn the creation and development of external-facing SaMD material (e.g., user manuals)Working closely with engineering and regulatory teams to streamline SaMD product delivery and maintain compliance with relevant standardsOversee SaMD usability testingAbout youYou will be experienced in the SaMD product sector while also possessing a compelling background in agile software development practices.
You may have strategic ability, but the immediate need of this role is to be in the weeds alongside the team every day.
Being detail oriented is critical because after six months the expectation is this role will own their processes and management of documentation, production and compliance.Strong product ownership or management experience working in Class II or Class III Software as a Medical Device companies.Must have worked on multiple medical device products and ideally across multiple regions.You must have work in medical device product development standards such as IEC 62304, ISO 14971).Must have exceptional written and verbal communication skills.You must be experienced in modern agile product development practices, and experience bringing best practices to SaMD processes is highly desired.Experience with cloud-hosted AI diagnostic SaMD products is highly desired.You must be team oriented and collaborative.Bachelor's degree or equivalent in the life sciences, healthcare, or related field is highly valued.
Advanced degree in vision sciences, biology, engineering, clinical research, or a similar field is a big plus.What's nextIf this sounds like a great opportunity, please apply today.
We will be reviewing applications over the coming weeks, and contacting shortlisted applicants for a phone screen before interviewing with the client.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionProduct Management and Information TechnologyIndustriesTechnology, Information and Media and Medical Equipment Manufacturing
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