Compliance Engineer

Job Description

The Digital Engineering team is focused on improving patient outcomes and delighting our customers. We support customer workflows, access to patient management and clinical data, support patient engagement, and offer both UI and API-based solutions backed by cloud-native microservices. The team works across virtually all functions in the company. We focus on complete, end-to-end ownership of the software development lifecycle.

Responsibilities

• Work with software development teams to ensure all regulatory and company requirements are met.
• The face of the Audits: Act as SME for all the audits for ResMed's digital products. Represent ResMed Engineering in audits, including but not limited to HDS, MDSAP, SOC2, and MDR.
• Technical Design Review: Identify and evaluate technical design alternatives to achieve desired functionality in partnership with cross-functional team members and Systems Architecture Leaders. Educate the engineering teams on the design review needs and facilitate the design review process among those teams.
• Enhance or modify existing design review processes. Help resolve technical issues.
• Safety Risk Analysis: Drive the bug-triage process and help determine issues that impact patient safety. Participate in the product roadmaps and influence the release of features based on safety risk analysis. Act as a bridge between Product Engineering and ResMed Quality/Regulatory teams and bring knowledge on the latest safety-related standards.
• Apply expert regulatory knowledge: Tackle intrinsically challenging problems with implication to regulatory requirements from around the world.
• System Specification: Ensure the company's technical compliance with applicable laws and regulations. Collaborate with engineers and designers to deliver compliant products and services.
• Responsible for researching and identifying applicable regulatory and industry compliance standards and codes. Ensure product achieves performance, functionality and reliability as specified in the marketing and systems specification documents.
• Deployments: Act as SME for formal releases to ensure meeting all the needed compliance and regulatory-related deployment documentation.
• Post Market Risk Assessment: Prepare compliance reports by collecting, analyzing, and summarizing measurement data and trends related to post-launch market data.

Qualification and Experience

• 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 MDSAP, ISO13485:2016, IEC62304, SOC2 controls.
• 3 years of experience delivering medical products and navigating through 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).

What You Can Expect

• A supportive environment that focuses on people development and best practices, with support both in and out of the work environment.
• Opportunity to design, influence, and be innovative.
• Work with global teams and share new ideas.
• Build something meaningful that lead to direct, positive impacts on people's lives.
• Comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
• Paid Time Off (PTO) in the first year of employment, 11 paid holidays plus 3 floating days, and eligibility for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.
• Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.
• A reasonable estimate of the current base range for this position is: $91,000 - $113,000 USD.