Senior Product Manager, SaMD

Location:

Canada (Winnipeg or Toronto preferred, remote possible)

At Klinrisk, we’re transforming how chronic disease is predicted, diagnosed, and managed. Klinrisk is setting a new precedent in prognosis, using clinically validated AI to turn routine lab test results into actionable insights. Built on the groundbreaking research of Dr. Navdeep Tangri, a globally recognized leader in disease risk prediction, Klinrisk bridges world-class science with real-world impact. In the past twelve months, the company has accelerated rapidly, achieving European approval (CE Mark) in partnership with Roche for the Kidney Klinrisk Algorithm, announcing a strategic collaboration with Renvio to embed predictive intelligence directly into kidney care workflows, and completing a successful fundraise to support ambitious team growth.

As Klinrisk scales across healthcare systems, this is a rare opportunity to join a fast-growing company at the forefront of AI-powered medicine and help shape the future of patient care.

Klinrisk is hiring a Senior Product Manager to own what we build and why. You hold the requirements, the roadmap, and the release plan for two products: a set of chronic disease prognostic tests (SaMD) and the related care quality analytics platform.

You report to the CEO. You work across engineering, quality, regulatory, operations, and commercial. You write requirements a lay reader understands and an engineer can build. You pull the right stakeholder in early, and you say no when a request adds risk without value.

Own product requirements across Klinrisk products and regions, turning clinical science and customer needs into specifications engineers can test

Write user stories and acceptance criteria, then sequence the backlog into releases

Trace every requirement to its specification, and document every release with notes, known issues, and updates to training material

Run impact and risk assessments using change control procedures

Bring software architecture, quality, and regulatory into the appropriate design stage, not after

Communicate tradeoffs, priorities, and timelines to technical and non-technical stakeholders

Improve the standard operating procedures (SOPs) that govern SaMD design, development, and release

Run discovery with clinical users, customers, and key opinion leaders (KOLs), then convert what you learn into the roadmap

Set success metrics for each release, then feed complaints and field signals back into the backlog

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

Ability to write requirements that satisfy engineers and auditors

Clear communication with technical and non-technical stakeholders

Experience shipping artificial intelligence (AI) or machine learning (ML) features in a regulated product

Experience integrating with clinical systems (e.g., EHR, LIS, HL7, FHIR)

Working knowledge of health data privacy (e.g., HIPAA, GDPR) and cybersecurity (e.g., SOC
2)

Experience releasing SaMD across multiple regions (e.g., United States, European Union)

Fluency with requirements and traceability tools (Ketryx, Jira, Codebeamer, or similar)

Software or clinical training

Prior experience as a first or early product hire

Working knowledge of diagnostics reimbursement and payor dynamics

Strong technical judgement under ambiguity and time pressure

Ability to balance urgency with long-term sustainability

Delivers…