Head of QA/RA (SaMD)

<img src="https://app.gurulink.ca/img/gl_logo_112x112.jpg" border="0"> Location: REMOTE / Winnipeg, Manitoba - Canada Job Type: Permanent Description:The client is a healthcare AI company turning routine lab results into clinically validated chronic disease risk predictions. Their algorithm is CE marked in Europe through a partnership with a global diagnostics company and is being embedded into specialty care workflows through a second strategic partnership. They closed a funding round in the past year and are growing the team fast. THE OPPORTUNITY This is the company's first Quality Assurance and Regulatory Affairs leader. You report to the CEO, sit on the leadership team, and run QA/RA as its own pillar of the business. You start hands-on and build the function as the product pipeline moves through FDA. You own the quality management system and the regulatory submissions that make this a Software as a Medical Device (SaMD) company. The products are AI-driven prognostic algorithms built on routine lab data, and FDA authorization of novel devices is a near-term priority. You work across product, engineering, clinical, data science and operations, take a risk-based approach to every QA control, and hold the line when a decision adds patient risk without benefit. WHAT SUCCESS LOOKS LIKE • A company-wide QMS built and running, compliant with ISO 13485 and FDA QMSR, and through certification. • FDA pre-submissions and De Novo requests led and moving toward authorization. • Design control, risk management (ISO 14971) and change control templates built with engineering and actually used. • Analytical and clinical validation studies designed with clinical and data science leaders to support product claims. • A clear plan for which QA/RA work stays with consultants and vendors, which comes in-house, and who gets hired as the team grows. DAY TO DAY • Own 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 with product, engineering and commercial leaders. • Own post-market surveillance, including real-world performance monitoring of AI models, registrations, labeling and quality agreements with partners. • Run QMS training for employees and teach engineers and business staff who are new to medical devices. • Manage QA/RA consultants and vendors, then hire and lead the QA/RA team. Must Have skills:• 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 and owned it through certification audit. • Led multiple SaMD marketing submissions (De Novo, 510(k) or 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). • Hands-on delivery of QA/RA artifacts (procedures, technical file components, marketing submissions) at more than one SaMD company. • Secured marketing authorization for a SaMD product in more than one region (US, EU MDR). • Early QA/RA hire (team under 5) at a growth-stage SaMD company. • Working knowledge of health data privacy (HIPAA) and security standards (ISO 27001). • Strong communicator who can teach engineers and business stakeholders who are new to medical devices. Nice to have skills:• De Novo experience for a diagnostic or prognostic product. • FDA authorization for multiple diagnostic or prognostic products on one platform (e.g., several lab analysis or imaging products). • In vitro diagnostic (IVD) or laboratory-based analytical software. • AI or ML SaMD, including Predetermined Change Control Plans (PCCPs). • SaMD used outside specialty care or inpatient settings (e.g., primary care). • Complaint handling through CRM tooling (Salesforce, HubSpot).

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