Head of SaMD Quality Regulatory Affairs
GuruLink
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.
#J-18808-LjbffrVacancy posted 6 hours ago
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