Compliance Engineer

San Diego, CA, United States💼 Full-time💰 $91,000–$91,000🗓 2024-11-06 → 2026-09-25

Core

Ensure technical compliance and audit readiness for digital medical products, acting as the SME for regulatory audits and safety risk analysis.

Role type

Compliance Engineer (Medical Device/Health Tech)

Builds

Compliant digital health products and audit-ready documentation

Domain

Medical Device / Health Technology / Regulatory Compliance

Deliverable

dashboards & analysis | client delivery

Required skills

Regulatory frameworks (MDSAP, ISO13485, IEC62304, SOC2), Software Product Life Cycle (SDLC), Technical design review, Safety risk analysis, Audit representation, Report writing

Preferred skills

Medical product delivery experience, MDR/HDS audit navigation

Technologies

None explicitly listed

Responsibilities

Act as SME for audits (HDS, MDSAP, SOC2, MDR); Conduct technical design reviews for compliance; Drive bug-triage and safety risk analysis; Ensure technical compliance with global regulations; Prepare compliance reports from post-market data

Seniority

Mid-level, hands-on IC

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About Resmed

We pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD, and other chronic diseases. Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice. By enabling better care, we improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems in mo