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.

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