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Oracle · 9 hours ago

Principal TPM, SaMD (Remote)

United States

Full-time

Remote

Senior Level, Lead/Staff

$90K/yr - $200K/yr

5+ years exp

Oracle is a world leader in cloud solutions, and they are seeking a Principal TPM to drive programs integrating SaMD regulatory requirements into engineering workflows. This role involves cross-functional leadership, ensuring compliance with medical device standards and facilitating the development of healthcare solutions.

Data GovernanceData ManagementEnterprise SoftwareInformation TechnologySaaSSoftware

No H1B

U.S. Citizen Only

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) AI Management 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

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

SaMD regulatory experienceIEC 62304ISO 13485Technical program managementCybersecurity-by-designCloud environmentsUsability engineeringExecutive presentationCommunicationTechnical writing

Required

Bachelor's degree in Computer Science, Engineering, or related technical field

Regulated medical device 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

5+ 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)

Preferred

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, DevSecOps workflows, and traceability tooling

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

Certifications in project management, cloud architecture, or medical device/healthcare compliance

Benefits

Medical, dental, and vision insurance, including expert medical opinion

Short term disability and long term disability

Life insurance and AD&D

Supplemental life insurance (Employee/Spouse/Child)

Health care and dependent care Flexible Spending Accounts

Pre-tax commuter and parking benefits

401(k) Savings and Investment Plan with company match

Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.

11 paid holidays

Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.

Paid parental leave

Adoption assistance

Employee Stock Purchase Plan

Financial planning and group legal

Voluntary benefits including auto, homeowner and pet insurance