Job Specifications
Brooksource is seeking an experienced Compliance Engineer to join our medical device cleint's Diagnostic Cardiology (DCAR) team. You will be responsible for ensuring that our product portfolio meets stringent regulatory and standard compliance requirements. This role is critical in supporting product design and development through comprehensive regulatory assessments, coordination and execution of compliance testing, and creation of deliverables that are essential for FDA submissions and internal approvals.
You will act as the bridge between highly technical testing standards and business leaders, simplifying complex compliance requirements into clear, actionable recommendations. A successful candidate will possess hands-on experience with compliance testing, medical device regulations, and taking products through the full development and compliance lifecycle. This is a contract-to-hire role.
Key Responsibilities:
• Own and execute compliance programs for DCAR products in alignment with evolving regulatory and standard requirements such as RoHS, REACH, PFAS, EMC, cybersecurity, usability, and safety standards.
• Coordinate end-to-end compliance testing activities, including: upfront assessments, defining test scope, test execution, and review of third-party lab results.
• Translate regulatory requirements (including legal/standard documents) into clear technical
implementation plans and communicate them effectively to cross-functional teams and leadership.
• Prepare comprehensive verification summaries and test reports in support of FDA and global
regulatory submissions.
• Assess the compliance impact of product design changes and new developments, ensuring alignment with standards from initial concept through to final release.
• Ensure documentation and testing procedures meet internal quality processes and external regulatory expectations.
Qualifications:
• 3–5 years of experience in compliance engineering or regulatory testing, ideally within the medical device or healthcare technology industry.
• Proven experience with IEC 60601-1 and 60601-1-2 compliance is mandatory.
• Experience with IEC 60601-2-25 is strongly preferred.
• Understanding of both software and hardware (electrical/mechanical) components of product design.
• Strong experience coordinating with third-party labs and interpreting their outputs.
• Ability to work across disciplines and clearly articulate technical findings to stakeholders with varying levels of technical expertise.
Preferred Skills:
• Familiarity with global regulatory frameworks including FDA submissions and CE marking.
• Strong project management and documentation skills.
• Experience working in cross-functional environments with R&D, Quality, and Regulatory teams.
• Ability to synthesize complex information into concise, leadership-ready communication.
About Eight Eleven Group Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.
About the Company
Here at Brooksource, relationships are at the center of everything we do. Since 2000, we have established and maintained lasting relationships with our clients, consultants, and internal employees to create an unparalleled experience.
Brooksource is a trusted provider of Engineering & Technology solutions for Fortune 500 organizations, specializing in Experience-Driven Staffing, Professional Services, and our innovative Workforce Transformation program, Elevate. Leveraging our partnerships with Salesforce, AWS, Microsoft, ...
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