Head Of Samd Quality Regulatory Affairs

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 submissionsLead FDA pre-submissions and De Novo requestsManage CAPA, complaints, audits, and management reviewsDevelop design, risk, and change control processesLead consultants, vendors, and future QA/RA hiresRequirements:
10+ years in medical device QA/RA5+ years working with SaMD3+ years leading QA/RA programs or teamsSaMD QMS certification experience under ISO 13485Fluency with IEC 62304, ISO 14971, and FDA guidanceShape FDA authorization, QMS certification, and risk-based controls for AI-driven prognostic SaMD products.
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