Senior Regulatory Technical Documentation Engineer; MDR Focus

Position: Senior Regulatory Technical Documentation Engineer (MDR Focus)

Job Description

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.

About the Role

To support these efforts, we are hiring Regulatory Technical Documentation Engineers with a deep engineering background, 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 – IC3

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 life cycles
  • 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)

• 5 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 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).

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.

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…