Regulatory Compliance Engineer: Medical Devices & Audits

ResMed Inc; Halifax; On-site; CAD 130,000 - 161,000; Full time

Job summary

ResMed is seeking a Compliance Engineer to partner with engineering managers and scrum teams to build and maintain regulatory-compliant digital products. You will apply knowledge of global standards and lead audits across MDR, SOC2, MDSAP, and related frameworks while supporting product design with compliant lifecycle practices.

The role emphasizes technical diligence, risk assessment, and clear reporting to ensure patient safety and product quality in a complex regulatory landscape.

Qualifications

• BS/MS in any engineering discipline.
• Computer science preferred.
• No hands-on coding experience is needed.
• Working knowledge of regulations including but not limited to MDR, MDSAP, ISO13485:2016, IEC62304, SOC2 controls.
• 3 years of experience delivering medical products and navigating audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework is a plus.
• Proficiency in report writing, analysis, and compliance procedures.
• Thorough understanding of regulatory frameworks.
• Solid technical knowledge and understanding of Software Product Life Cycle (SDLC).

Responsibilities

• Act as SME for audits of ResMed's digital products. Represent ResMed Engineering in audits (HDS, MDSAP, SOC2, MDR).
• Technical Design Review: identify and evaluate design alternatives with cross-functional teams and educate engineers on design review needs.
• Safety Risk Analysis: drive bug-triage and influence release timing based on safety risk analysis.
• Apply expert regulatory knowledge to global regulatory requirements.
• System Specification: ensure compliance across laws and collaborate with teams to deliver compliant products.
• Deployments: act as SME for formal releases and regulatory documentation.
• Post Market Risk Assessment: prepare compliance reports from data trends.

Skills

Regulatory compliance

Audits experience

SDLC knowledge

Report writing

Regulatory frameworks

Education

BS/MS in engineering

Computer science background preferred

Job description

ResMed is seeking a Compliance Engineer to partner with engineering managers and scrum teams to build and maintain regulatory-compliant digital products. You will apply knowledge of global standards and lead audits across MDR, SOC2, MDSAP, and related frameworks while supporting product design with compliant lifecycle practices.

The role emphasizes technical diligence, risk assessment, and clear reporting to ensure patient safety and product quality in a complex regulatory landscape.