Lead SaMD quality and regulatory affairs remotely from Winnipeg, Manitoba, with expertise in FDA submissions and ISO 13485 systems.
As the healthcare AI company's first QA/RA leader, you report to the CEO and join its leadership team. You will build the quality function while AI-driven prognostic algorithms move toward FDA authorization. The work spans product, engineering, clinical, data science, and operations.
Key Responsibilities: Own the quality management system and regulatory submissions
Lead FDA pre-submissions and De Novo requests
Manage CAPA, complaints, audits, and management reviews
Develop design, risk, and change control processes
Lead consultants, vendors, and future QA/RA hires
Requirements: 10+ years in medical device QA/RA
5+ years working with SaMD
3+ years leading QA/RA programs or teams
SaMD QMS certification experience under ISO 13485
Fluency with IEC 62304, ISO 14971, and FDA guidance
Shape FDA authorization, QMS certification, and risk-based controls for AI-driven prognostic SaMD products.

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📌 Head of SaMD Quality Regulatory Affairs (Manitoba)
🏢 GuruLink
📍 Manitoba