Head of SaMD Quality Regulatory Affairs
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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-Ljbffr
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