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. **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. **Responsibilities** + 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. + 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). **Preferred Qualifications** + 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. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $90,100 to $199,500 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. 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. 9. 11 paid holidays 10. 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. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC4 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing [email protected] or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.