Cambrionix
Quality Assurance Regulatory Affairs Manager
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Role Overview
We are seeking an experienced freelance QARA Manager for a 6-month contract to lead global regulatory compliance and quality assurance for our hardware product portfolio. Operating on a hybrid basis from our Cambridge office, you will collaborate closely with our internal engineering team and coordinate directly with our contract manufacturers. You will own the re-certification processes for CE, BIS, and UL, manage EMS and RoHS compliance, and ensure all existing products and New Product Introductions (NPI) meet stringent international standards.
Key Responsibilities
Regulatory Re-Certification & Compliance
- Lead and execute re-certification projects for existing hardware products, specifically focusing on CE, BIS, and UL marks.
- Maintain, update, and manage Technical Files, Declarations of Conformity, and regulatory documentation.
- Act as the primary point of contact for external test houses, notified bodies, and regulatory agencies.
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Environmental & Materials Compliance
- Oversee and ensure full compliance with RoHS, REACH, and WEEE directives across all product lines.
- Manage Environmental Management System (EMS) requirements and alignment with relevant standards.
Lifecycle & Cross-Functional Collaboration
- Collaborate with the internal engineering team to retrieve technical drawings, schematics, and component data.
- Proactively monitor, analyze, and manage upcoming global regulatory changes impacting current products.
- Implement necessary engineering change orders (ECOs) to maintain continuous market compliance.
Supply Chain & NPI
- Travel to contract manufacturers to audit production compliance, resolve quality issues, and align on testing processes.
- Serve as the QARA lead on NPI teams to embed compliance requirements into early product design.
- Define compliance roadmaps, testing strategies, and certification schedules for new hardware launches.
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Qualifications and Experience
- Experience: 5+ years in QARA roles within hardware, electronics, or manufacturing.
- Certifications: Proven track record securing and maintaining CE, BIS, and UL certifications.
- Standards Knowledge: Deep technical expertise in RoHS, REACH, and EMS frameworks.
- Collaboration: Experience partnering with internal engineering teams and managing contract manufacturers.
- Mobility: Willingness and ability to travel to contract manufacturing sites as required.
- Efficiency: Ability to operate autonomously and deliver results within a 6-month window
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