Software Development Compliance DirectorVirtualVocations • Saginaw, Michigan, United States
Software Development Compliance Director
VirtualVocations • Saginaw, Michigan, United States
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A company is looking for an Associate Director of Software Development Compliance.
Key Responsibilities
Define and maintain a compliant software development lifecycle integrated with quality management system processes
Ensure alignment of software development artifacts with regulatory design controls and objective evidence expectations
Lead verification and validation activities, ensuring compliance with relevant standards and guidelines
Required Qualifications
At least 8+ years of experience in software development compliance in a regulated medical device or diagnostics environment
Deep working knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR 820.30
Proven track record leading requirements engineering and software verification functions
Experience with Class II and III regulatory applications, particularly for IVD software products
Experience collaborating with cross-functional teams, including software developers and quality assurance members
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Director Compliance • Saginaw, Michigan, United States
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