Head of QA/RA

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 its Quality Assurance and Regulatory Affairs (QA/RA) leader. You start hands-on and build the function as our pipeline moves through FDA. You own the quality management system (QMS) and the regulatory applications that make Klinrisk a software as a medical device (SaMD) company. Our products are AI-driven prognostic algorithms built on routine lab data, and FDA authorization of novel devices is a near-term priority.

You report to the Chief Executive Officer, sit on the leadership team, and run QA/RA as an independent pillar of the business. You work across product, engineering, and operations. You implement a risk-based approach to all QA control implementation, and you hold the line when a decision adds patient risk without benefit.

Responsibilities

  • Build and run a company-wide QMS, compliant with ISO 13485 and FDA QMSR

  • Partner with engineering to create and improve our production templates (e.g., design control SOPs, risk management (ISO 14971), change control)

  • Own execution of corrective and preventive action (CAPA), complaint management, nonconformances, internal audits, and management review

  • Serve as management representative and lead certification and regulator audits

  • Contribute to global regulatory strategy for current and future products in partnership with product, engineering, and commercial leaders

  • Lead device marketing applications, e.g., FDA pre-submissions, De Novo requests

  • Partner with clinical and data science leaders to design analytical and clinical validation studies that support product claims

  • Own post-market surveillance, including real-world performance monitoring of AI models, registrations, labeling, and quality agreements with partners

  • Manage QA/RA consultants and vendors, decide what to bring in-house, and hire and lead the QA/RA team as the company grows

  • Facilitate employee QMS training

Requirements

  • 10+ years in medical device QA/RA, including 5+ years with SaMD and 3+ years leading QA/RA programs or teams

  • Built a SaMD QMS to ISO 13485, then owned it through certification audit

  • Led multiple SaMD marketing submissions (e.g., De Novo, 510(k), premarket approval (PMA)) through FDA authorization

  • Fluency with IEC 62304, ISO 14971, and FDA software and cybersecurity guidance

  • Fluency with eQMS and traceability tools (Ketryx, Greenlight Guru, Jira, or similar)

  • Demonstrated hands-on delivery of QA/RA artifacts (e.g., writing procedures, technical file components, marketing submissions) at multiple SaMD companies

  • Exceptional communication skills with demonstrated ability to educate non-QA personnel (e.g., engineers) or business stakeholders who are new to the med device world

  • Experience securing marketing authorization a SaMD product across multiple regions (e.g., US, EU MDR)

  • Prior experience as an early QA/RA hire (<5 QA/RA team size) at a growth stage SaMD company

  • Working knowledge of health data privacy (e.g., HIPAA) and security standards (e.g., ISO 27001)

Preferred Qualifications

  • De Novo experience for a diagnostic or prognostic product

  • Experience obtaining FDA authorization for multiple diagnostics or prognostics products on one platform (e.g., image analysis products on one imaging modality, lab analysis products)

  • Experience with in vitro diagnostic (IVD) or laboratory-based analytical software

  • Experience with AI or machine learning (ML) SaMD, including PCCPs

  • Experience with SaMD used outside specialty care or inpatient settings (e.g., primary care)

  • Experience managing complaint processes via CRM service tooling (e.g., Salesforce, Hubspot)


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: We measure ourselves by what the customer achieves with Klinrisk, not by what we ship. When a customer is stuck we treat it as our problem to solve, even when the root cause sits outside our product.

  • Willing to own a new challenge: We step toward unfamiliar work that is owned by our "seat," or that no seat clearly owns yet, and we take accountability for the outcome rather than the effort. Owning a new challenge means getting it assigned and resourced properly - not working around the person who already owns it.

  • Focused on highest impact actions: We are small and commonly under-resourced during rapid growth, so we spend our time on the few things that move high-quality revenue, evidence, or compliance forward. We say no clearly, and we finish what we start before adding more.

Compensation & Equity

  • Salary range: $180,000-$240,000 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 experience and real comfort in regulated environments, apply and let’s talk.