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Medical Devices Quality Manager jobs in Cambridge

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Job Post Details

Quality Assurance & Regulatory Affairs (QARA) Manager - job post

Cambrionix
Cambridge•Hybrid work
£55,000 - £60,000 a year - Freelance

Job details

Pay

  • £55,000 - £60,000 a year

Job type

  • Freelance

Location

Cambridge•Hybrid work

Full job description

Role Overview
We are seeking an experienced 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.

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.

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

Pay: £55,000.00-£60,000.00 per year

Experience:

  • QARA roles within hardware, electronics, or manufacturing.: 5 years (required)
  • Deep technical expertise in RoHS, REACH, and EMS frameworks.: 3 years (preferred)

Work authorisation:

  • United Kingdom (required)

Work Location: Hybrid remote in Cambridge (Cambridgeshire, East of England Region)

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