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.
As a Compliance Engineer, you will work closely with our engineering managers, technical and feature leads, and scrum teams to provide engineering excellence in the areas of product compliance and audits. You will be responsible for developing and implementing the company's technical compliance capabilities according to local, national, and international regulatory standards. You will have a sound technical background and be up to date with the latest regulatory developments in the industry.
Let's talk about responsibilities:
The Compliance Engineer will work with software development teams to ensure all regulatory and company requirements are met. Responsibilities include:
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.
Let's talk about 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 ) .
Let's talk about 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 .
B uild something meaningful that lead to direct , positive impact s on people's lives.
With a 30 - year history of innovation as a global leader in health technology, we know those good ideas can come from anywhere at ResMed. Innovation and imagination aren't just something we aspire to; they are integral to the way we work. We work hard to provide the opportunity for every employee to do amazing things every day as we shape the future together. Join us as we improve the lives of hundreds of millions of people around the world together!
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.
At ResMed (NYSE: RMD, ASX: RMD) 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 more than 140 countries. To learn more, visit ResMed.com and follow @ResMed.
ResMed Corporation is an equal opportunity employer and provides equal opportunity in employment for all qualified persons, without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
(US/Canada only) ResMed is an equal opportunity/affirmative action employer. ResMed is an E-Verify Employer. ResMed is a smoke-free workplace.
We are a 2024 Circle Back Initiative Employer – we commit to respond to every applicant!
#J-18808-Ljbffr