Head of Quality Assurance and Regulatory Affairs (QA/RA)

Klinrisk; Winnipeg, Toronto; Hybrid; CAD 180,000 - 240,000; Full time

Benefits offered by this job

ESOP participation

Competitive benefits package

Job summary

Klinrisk is seeking a seasoned Quality Assurance and Regulatory Affairs leader to build and oversee QMS compliant with ISO 13485 and FDA QMSR for our AI-driven SaMD products. You will own regulatory applications, drive FDA submissions, and align QA with product, engineering, and operations.

You will report to the CEO, lead QA/RA as a core function, and implement risk-based controls. This senior role requires deep experience across ISO, IEC, and global regulatory pathways and a hands-on

Qualifications

• 10+ years in medical device QA/RA, incl. 5+ years with SaMD
• Led SaMD QMS to ISO 13485 and certification audits
• Led FDA submissions (De Novo, 510(k), PMA) for SaMD
• Fluency with IEC 62304, ISO 14971, FDA software and cybersecurity guidance
• Experience with eQMS/traceability tools (Ketryx, Greenlight Guru, Jira)
• Hands-on QA/RA artifacts across multiple SaMD companies
• Strong ability to educate engineers and business stakeholders
• Experience securing marketing authorization across US/EU MDR
• Early QA/RA hire experience at growth-stage SaMD
• Knowledge of HIPAA and ISO 27001

Responsibilities

• Build and run a company-wide QMS, ISO 13485 and FDA QMSR compliant
• Partner with engineering to create design control SOPs and risk management
• Own CAPA, complaint management, nonconformances, internal audits
• Serve as management representative and lead audits
• Contribute to global regulatory strategy with product leadership
• Design validation studies with clinical and data science teams
• Oversee post-market surveillance for AI models and labeling
• Manage QA/RA staff and vendors, scale the team as needed

Skills

QA/RA leadership

ISO 13485

FDA submissions

IEC 62304

Regulatory strategy

HIPAA / data privacy

Cross-functional collaboration

Communication

Tools

Ketryx

Greenlight Guru

Jira

Job description

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
• 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

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)

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