Principal TPM, SaMD; Remote

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.

• 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.

• Bachelor’s degree in Computer Science, Engineering, or related technical field.

• SaMD experience is mandatory —must have directly supported or led software programs governed by medical device regulations.

• Deep understanding of IEC 62304, IEC 82304, ISO 13485, ISO 14971 , and related IMDRF SaMD principles.

• 7 years of technical program management experience, including leading complex engineering programs in regulated environments.

• Demonstrated ability to translate regulatory requirements into technical workflows, SDLC practices, and automated compliance mechanisms.

• Strong leadership experience driving cross-functional initiatives with engineering, regulatory, clinical, and quality stakeholders.

• Excellent communication, technical writing, and executive presentation skills.

• Ability and willingness to obtain a Public Trust clearance (US citizens only).

• Experience integrating usability, cybersecurity, and safety engineering practices into SDLC (IEC 62366, IEC 81001-5-1, ISO/IEC 27001).

• Hands‑on experience preparing evidence packages for audits, notified bodies, or regulatory submissions.

• Familiarity with CI/CD compliance automation, Dev Sec Ops  workflows, and traceability tooling.

• Experience with cloud environments (OCI, AWS, Azure, or GCP) and secure SaaS delivery in regulated contexts.

• Certifications in project…