SaMD Principal Technical Program Manager

Location: United States

Oracle Health Applications & Infrastructure (OHAI) is modernizing the future of healthcare with a highly automated, intelligent, and resilient platform that powers clinical and operational workflows at global scale. As we expand our portfolio into regulated healthcare software domains, we are seeking an exceptional Principal Technical Program Manager with deep expertise in Software as a Medical Device (SaMD) to lead complex, cross-functional programs that ensure our products, SDLC practices, and release operations meet the highest regulatory and quality standards. This role will be instrumental in establishing the governance, technical program leadership, and regulatory alignment necessary to deliver safe, effective, compliant SaMD solutions within a cloud-native environment. SaMD experience is a strict requirement for this role.

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 Leadership

• Lead end-to-end planning and delivery of SaMD programs, ensuring adherence to IEC 62304 (software lifecycle processes) and IEC 82304 (healthcare software safety and security).
• Drive cross-functional alignment on regulatory, quality, and engineering needs for medical device-class software solutions.
• Establish program roadmaps, dependencies, milestones, and KPIs, ensuring disciplined execution and transparent reporting.

Regulatory & Quality Integration

• Collaborate with Quality, Regulatory, and Clinical teams to ensure product development conforms to ISO 13485, ISO 14971, EU MDR/IVDR expectations, and IMDRF SaMD risk frameworks.
• Ensure risk-based lifecycle management, traceability, hazard analysis, and post-market surveillance processes are embedded into SDLC activities.
• Translate regulatory requirements into clear engineering controls, documentation workflows, and change-management practices.

SDLC Governance & Automation

• Define and govern SDLC processes tailored to SaMD development, integrating:
  • Usability engineering (IEC 62366)
  • Cybersecurity-by-design (IEC 81001-5-1, ISO/IEC 27001)
  • AI Managmeent Systems ISO/IEC 42001
  • Cloud/SaaS delivery safety patterns
• Partner with engineering to embed compliance controls, checklists, templates, and automated evidence generation into CI/CD pipelines.
• Drive automation strategies for traceability, verification artifacts, configuration management, and release documentation.

Cross-Functional Leadership

• Serve as the central point of coordination across Engineering, Product, Security, Quality, Risk, Regulatory, and Operations.
• Influence architecture, delivery processes, and organizational priorities to ensure compliance, audit readiness, and continuous improvement.
• Develop executive-level summaries, dashboards, and presentations detailing SaMD program status, risks, and mitigation strategies.
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About Us

Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.

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Led cross-functional Software as a Medical Device (SaMD) programs, ensuring compliance with IEC 62304, IEC 82304, ISO 13485, ISO 14971, and IMDRF guidance while driving end-to-end program execution.