Senior Product Manager, SaMD

Location: Canada (Winnipeg or Toronto preferred, remote possible)

About Klinrisk

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.

About the Role

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.

Responsibilities

  • 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

Requirements

  • 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)

Preferred Qualifications

  • 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

Competencies

  • Strong technical judgement under ambiguity and time pressure

  • Ability to balance urgency with long-term sustainability

  • Delivers production ready systems under aggressive timelines

  • Maintains quality without over-engineering

  • Demonstrates ownership, accountability and follow-through

  • Communicates clearly with technical and non-technical stakeholders

  • Builds trust through transparency and consistency

  • Willingness to design and follow appropriate, compliant processes

  • Leads by example and invests in long-term team health

Klinrisk Core Behaviors

Klinrisk seeks team members with the following traits and expects these behaviors as we build the company together:

  • Obsessed with customer success

  • Willing to own a new challenge

  • Focused on highest impact actions

Compensation & Equity

  • Salary range: $160,000-$200,000 CAD

  • Equity: Employee Stock Option Plan (ESOP) participation at senior level

  • Benefits: Competitive benefits package

How to Apply

We recognize that the right person may not check every box. If you have hands-on SaMD product experience and real comfort in regulated environments, apply and let’s talk.