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Oracle · 1 month ago

Principal TPM, SaMD (Remote)

United States

Full-time

Remote

Lead/Staff

10+ years exp

Oracle is a leading technology company specializing in healthcare solutions. In this highly visible leadership position, you will drive programs that integrate SaMD regulatory requirements into engineering workflows and ensure compliance with global medical device standards.

Data GovernanceData ManagementEnterprise SoftwareInformation TechnologySaaSSoftware

No H1B

Responsibilities

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

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

Define and govern SDLC processes tailored to SaMD development, integrating: Usability engineering (IEC 62366) Cybersecurity-by-design (IEC 81001-5-1, ISO/IEC 27001) 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

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

Qualification

IEC 62304ISO 13485ISO 14971Regulatory complianceSDLC governanceAutomation strategiesUsability engineeringCybersecurityCloud delivery modelsCross-functional leadership