Location: REMOTE / Winnipeg, Manitoba
This job allows you to work remotely.
The client is a healthcare AI company turning routine lab results into validated chronic disease risk predictions. Their algorithms are clinically validated, CE marked in Europe through a partnership with a global diagnostics company, and now embedded into specialty care workflows through a second strategic partnership. They closed a funding round in the past year and are hiring aggressively.
THE OPPORTUNITY
This is the first dedicated product hire, reporting directly to the CEO. The person owns what gets built and why across two products: a set of chronic disease prognostic tests regulated as Software as a Medical Device (SaMD), and the care quality analytics platform that sits alongside them.
They hold the requirements, the roadmap, and the release plan. They work across engineering, quality, regulatory, operations, and commercial. They write requirements a lay reader can follow and an engineer can build against, pull the right stakeholder in early rather than late, and say no when a request adds regulatory risk without adding value.
WHAT SUCCESS LOOKS LIKE
• A single owned roadmap and release plan covering both products across all regions, replacing whatever requirements currently live in people's heads.
• Requirements traceability that holds up in an audit: every requirement traced to its specification, every release documented with notes, known issues, and updated training material.
• SOPs governing SaMD design, development, and release improved and actually followed, not shelfware.
• Regulatory, quality, and software architecture brought into the design stage instead of reviewing after the fact.
• A discovery cadence with clinical users, customers, and KOLs that feeds a prioritized backlog, with success metrics defined per release and field complaints routed back into it.
DAY TO DAY
• Own product requirements across products and regions, turning clinical science and customer needs into specifications engineers can test.
• Write user stories and acceptance criteria, sequence the backlog into releases.
• Run impact and risk assessments through change control procedures.
• Communicate tradeoffs, priorities, and timelines to technical and non-technical stakeholders.
Must Have Skills:
• 5+ years in product management, including 3+ years accountable for requirements and documentation across multiple Class II or Class III SaMD products.
• Hands-on agile product management: backlog, user stories, acceptance criteria.
• Working knowledge of IEC 62304, ISO 13485, ISO 14971, and design controls.
• Experience building and maintaining requirements traceability.
• Writes requirements that satisfy engineers and auditors both.
• Experience shipping AI or ML features inside a regulated product.
• Experience integrating with clinical systems (EHR, LIS, HL7, FHIR).
• Working knowledge of health data privacy (HIPAA, GDPR) and cybersecurity (SOC 2).
Nice to Have Skills:
• Released SaMD across multiple regions (US, EU).
• Fluency with requirements and traceability tools (Ketryx, Jira, Codebeamer, or similar).
• Software or clinical training.
• Prior first or early product hire.
• Working knowledge of diagnostics reimbursement and payor dynamics.
