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NIRSense Inc · 19 hours ago

Regulatory & Electrical Compliance Consultant

Morrisville, North Carolina, United States

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

NIRSense Inc is seeking a senior-level Medical Device Regulatory & Electrical Compliance Consultant to support preparation for IEC 60601-1 testing and certification. The role involves conducting a gap analysis and compliance roadmap, as well as producing submission-ready documentation for IEC 60601-1 ASCA-accredited test labs.

ManufacturingMedical DeviceSensor

Responsibilities

Review existing design, risk, and verification documentation and produce a complete, submission-ready documentation package for an IEC 60601-1 ASCA-accredited test lab

Review and assess the following documentation for IEC 60601-1 readiness: System Requirements, Hazard Analysis and Risk Management File (ISO 14971), DFMEA, Part Specifications and Bill of Materials (BOM), Requirements Traceability Matrix, System & Hardware Design Documentation, Design Review Records, Verification & Validation (V&V) documentation

Identify gaps across RMF, DHF, and V&V documentation related to IEC 60601-1, 60601-1-1, and 60601-1-2

Evaluate documentation completeness, traceability, and quality

Assess alignment with ASCA submission expectations

Prioritize gaps by risk and impact (critical / high / medium / low)

Gap Analysis Report, including: Identified deficiencies across RMF, DHF, and V&V, Risk-based prioritization of gaps, Clear recommendations for remediation

Compliance Roadmap, including: Documentation task list to close gaps, Recommended Phase 2 execution model (templates, full documentation, hybrid, or review), Dependencies and sequencing, Preliminary effort estimate and scope guidance for Phase 2

Phase 2 scope, timeline, and commercial terms will be defined following completion of Phase 1 and may include: Full documentation development, Template creation and client training, Hybrid documentation support, Review and remediation of client-authored documentation

Qualification

IEC 60601-1 complianceISO 14971 risk managementMedical device regulatory experienceFDA 510(k) pathwaysElectrical safety experienceGap analysisDesign history file remediationWearable device experienceDocumentation preparation