Oracle
Columbus, OH, USA
Job Description In this highly visible leadership position, you will drive programs that integrate SaMD regulatory requirements into engineering workflows, SDLC practices, release processes, and cloud delivery models. You will partner closely with Engineering, Product, Quality, Regulatory, Clinical, Security, and Compliance teams to ensure Oracle's healthcare solutions align with global medical device standards, including IEC 62304, IEC 82304, ISO 13485, ISO 14971 , and related IMDRF SaMD guidance. You will own cross-organization planning, execution, and delivery accountability for SaMD initiatives-translating regulatory requirements into actionable engineering backlogs, creating scalable quality system processes, and enabling automation for audit readiness. Your work will ensure our software development practices meet the expectations for medical device safety, risk management, usability, security, and post-market surveillance. Key Responsibilities SaMD Program...


