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NetSuite · 1 month ago

Princiipal Regulatory Technical Documentation Engineer

United States

Full-time

Remote

Senior Level, Lead/Staff

$97K/yr - $223K/yr

6+ years exp

NetSuite is a world leader in cloud solutions, and they are seeking a Principal Regulatory Technical Documentation Engineer to support their MDR compliance efforts. The role involves producing regulatory documentation, managing risk assessments, and collaborating with engineering teams to ensure compliance with regulatory standards.

Cloud ComputingComputerCRMiOSSaaSSoftware

No H1B

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

MDR documentationISO 14971Cloud-native systemsTechnical writingRisk managementTechnical architectureAWSAzureGCPOCISoft skills

Required

8+ 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