Oracle · 2 weeks ago
Senior Principal Regulatory Technical Documentation Engineer (MDR Focus)
United States
Full-time
Remote
Senior Level, Lead/Staff
$97K/yr - $252K/yr
10+ years expOracle Health Data Intelligence is entering a high-impact phase of MDR readiness and regulatory transformation. They are seeking a Senior Principal Regulatory Technical Documentation Engineer to own and produce MDR-required documentation and support compliance efforts across their AI-enabled healthcare platform.
Data GovernanceData ManagementEnterprise SoftwareInformation TechnologySaaSSoftware
Responsibilities
Own and produce MDR-required artifacts, including Design History Files (DHF), Technical Files, Software Architecture documentation, Traceability Matrices, and Verification Plans
Update and maintain ISO 14971-compliant risk management files, hazard analyses, and FMEAs
Collaborate with Regulatory, MDR Program leadership, and Risk Management TPMs to align documentation with audit expectations
Translate complex distributed system architecture (cloud-native, multi-region) into clear regulatory documentation
Document engineering workflows across large-scale data platforms:
Data ingestion pipelines
ML model lifecycles
Security + identity management
Observability, CI/CD, deployment processes
Work with engineering leaders (e.g., Priyank’s teams) to ensure designs are accurately captured
Partner with engineering, applied science, product, and regulatory leaders to gather technical inputs
Work with third-party regulatory consultants to incorporate their recommendations
Support audit readiness activities throughout 2025–2026
Qualification
Required
10+ years in software engineering, systems engineering, or technical architecture
Experience in a hyperscaler environment (AWS, Azure, GCP, or OCI) OR large-scale distributed systems
Demonstrated experience writing technical design documents, system diagrams, and architecture descriptions
Strong understanding of secure cloud computing, microservices, distributed data systems, or enterprise software
Ability to translate engineering complexity into structured documentation for regulatory consumption
Experience with one or more of: MDR (Medical Device Regulation), ISO 14971 (risk management), ISO 13485, IEC 62304, SaMD (Software as a Medical Device) documentation
Experience preparing documentation for audits, technical files, or regulatory submissions
Preferred
Experience in healthcare, life sciences, or regulated cloud software
Prior work with quality assurance teams (QMS, design controls)
Experience working directly with regulatory or risk management stakeholders
Prior experience documenting AI/ML systems is a bonus (HDI relevance)
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
Company
Oracle
Oracle is an integrated cloud application and platform services that sells a range of enterprise information technology solutions.
10001+ employees
H1B Sponsorship
Oracle has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1271)
2024 (846)
2023 (995)
2022 (1192)
2021 (985)
2020 (755)
Funding
Current Stage
Public CompanyTotal Funding
$25.75BKey Investors
Sequoia Capital
2025-09-24Post Ipo Debt· $18B
2025-02-03Post Ipo Debt· $7.75B
1986-03-12IPO
Leadership Team
Esteban Rubens
Healthcare Field CTO
G
Gerard Warrens
Field CTO, Business Strategy and Transformative Technologies
Recent News
2026-01-12
The Motley Fool
2026-01-12
Company data provided by crunchbase