Compliance Engineer

About the role

The Digital Product Engineering organization builds and manages a portfolio of digital offerings that support connected care. As a Compliance Engineer, you will work with engineering managers, technical and feature leads and scrum teams to provide engineering excellence in product compliance and audits. You will develop and implement the company's technical compliance capabilities according to local, national and international regulatory standards.

Key responsibilities

• Act as subject matter expert for audits of ResMed's digital products, representing the company in audits such as HDS, MDSAP, SOC2 and MDR.
• Take part in technical design reviews, evaluating alternatives and educating engineering teams on design review needs.
• Drive the bug-triage process, identify issues affecting patient safety and influence feature releases based on safety risk analysis.
• Ensure technical compliance with applicable laws and regulations, research standards and codes, and make sure products meet the specifications in marketing and systems documents.
• Support formal releases by ensuring compliance and regulatory deployment documentation is complete.
• Prepare post-market compliance reports by collecting, analysing and summarising post-launch data.

Required profile

• BS/MS in any engineering discipline; computer science preferred.
• No hands-on coding experience required.
• 3 years of experience delivering medical products and navigating audits such as MDR, SOC2, MDSAP or HDS is a plus.

Required skills

• Working knowledge of regulations such as MDSAP, ISO 13485:2016, IEC 62304 and SOC2 controls.
• Thorough understanding of regulatory frameworks.
• Solid technical knowledge of the software product life cycle (SDLC).
• Proficiency in report writing, analysis and compliance procedures.

What we offer

• Estimated base salary of $91,000 - $113,000 USD.
• Medical, vision, dental, life, AD&D, short- and long-term disability insurance, HSA, FSA, commuter benefits, 401(k), ESPP, EAP and tuition assistance.
• 15 days PTO in the first year, 11 paid holidays plus 3 floating days, and caregiver leave.
• Flexible work arrangements and a supportive, people-focused environment.