Compliance Engineer

DBA-Verwaltungs-Gmbh; San Diego (CA); On-site; USD 91,000 - 113,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(k) plan

Tuition assistance

Paid Time Off

Job summary

DBA-Verwaltungs-Gmbh is seeking a Compliance Engineer to enhance compliance for digital health products. You will oversee audits, ensuring adherence to international regulatory standards like MDSAP and ISO13485. You'll collaborate with engineering teams to deliver compliant solutions, conduct safety risk analyses, and drive continuous improvement processes.

This role provides a unique opportunity to make an impact in healthcare technology with a supportive environment that emphasizes professional development. The company offers a comprehensive benefits package including medical, education assistance, and paid time off.

Qualifications

• 3 years of experience with medical product compliance and audits.
• Proficiency in report writing and compliance procedures.
• Thorough understanding of regulatory frameworks.

Responsibilities

• Act as SME for audits of digital products.
• Identify and evaluate design alternatives for compliance.
• Drive bug-triage process affecting patient safety.

Skills

Regulatory knowledge

Communication skills

Risk analysis

Technical design evaluation

Education

BS/MS in engineering or computer science

Job description

The Digital Product Engineering organization powers digital experiences and engagement to enhance the lives of millions of people every day through connected care. We build, deliver, and manage a divers portfolio of offerings supporting our core businesses. We thrive on simple and elegant architecture and agility. You'll be immersed in a dynamic, high-growth environment and empowered to excel, take informed risks, and drive ingenuity across the enterprise.

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.

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.

Responsibilities

• 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.

Qualifications 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.

Benefits

This position qualifies for the following benefits package: 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. Employees scheduled to work 30 or more hours per week are eligible for benefits.

Employees receive fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible 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. At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current base range for this position is: $91,000 - $113,000 USD.