Note: The job is a remote job and is open to candidates in USA. Oracle is modernizing the future of healthcare with a highly automated platform and is seeking a Principal Technical Program Manager with expertise in Software as a Medical Device (SaMD). This role will lead complex programs ensuring compliance with regulatory standards while integrating SaMD requirements into engineering workflows.
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
Skills
- 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)
- 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
- May be eligible for bonus and equity
Company Overview