Senior Principal Regulatory Technical Documentation Engineer

Job Description
About the Role
Oracle Health Data Intelligence is entering a high-impact phase of
MDR (Medical Device Regulation)
readiness and
regulatory transformation
. Over the next year, HDI must execute a large volume of
technical documentation, risk management activities, and engineering design updates
required for compliance across our AI-enabled population health platform.

To support these efforts, we are hiring
Regulatory Technical Documentation Engineers
with
deep engineering backgrounds
, strong technical writing skills, and experience in hyperscaler-style environments (cloud-native, large-scale distributed systems, secure compute, data pipelines).

These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment—removing this burden from engineering leaders and accelerating our compliance timelines.

Career Level - IC5

Responsibilities
What You Will Do
In this role, you will be responsible for the engineering documentation work that was kicked off this week in the MDR software design initiative, including:

MDR & Regulatory Execution

• 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.

Engineering Documentation for Hyperscale Healthcare Systems

• 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.

Cross-Functional Partnering

• 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.

What We're Looking For :
Required (Core)

• 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.

Required (Regulatory / Health Tech)

• Experience with one or more of:

• MDR (Medical Device Regulation)

• ISO 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).

Why This Role Matters
HDI is undergoing a major MDR compliance effort that spans:

• Population health data platforms
• AI/ML systems
• Cloud-native healthcare services
• Risk management modernization

Engineering leaders today are carrying the documentation and risk management workload.

This role
takes over that responsibility
, providing:

• Dedicated regulatory documentation ownership
• Faster MDR readiness
• Stronger engineering–regulatory alignment
• Reduced risk and audit exposure

This is a
high-impact
role that directly enables Oracle Health to meet regulatory requirements, maintain compliance across global markets, and support safe, scalable deployment of AI-enabled healthcare solutions.

Qualifications
Provide leadership and expertise in the development of new products/services/processes, frequently operating at the leading edge of technology. Recommends and justifies major changes to existing products/services/processes. BS or MS degree or equivalent experience relevant to functional area. 8 or more years of software engineering or related experience.

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 accommodation- or by calling 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.