Ernest Gordon Recruitment
Compliance Engineer (Medical Equipment)
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Compliance Engineer (Medical Equipment)
Compliance Engineer (Medical Equipment)
Location: Cheltenham, England Salary: £50,000 - £55,000 + Career Progression + In-house Training + Pension + Company Benefits
About the Role
Are you a dedicated Compliance Engineer or similar with a background in Medical Product Testing, seeking an exciting opportunity to work for a market-leading company that is passionate about what they do, offering multiple pathways for development and career progression?
This company specialises in accessibility solutions, known for its innovative technologies that develop high-performance products addressing specific requirements for various situations and individuals. The organization promotes a collaborative work culture encouraging continuous improvement and employee development.
In this role, you will:
- Oversee all aspects of legislative compliance and product safety
- Ensure all products meet relevant standards through rigorous testing and documentation
- Maintain a comprehensive compliance database
- Participate in product design for certification
- Conduct training to uphold compliance
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This role befits a Compliance Engineer who thrives on the pride of their work and is eager to join a market-leading company with opportunities for growth.
Responsibilities (The Role)
- Act as the technical authority on legislative compliance and product safety
- Conduct detailed testing on new and existing products, generating reports for documentation
- Maintain and update product approvals and certifications in line with current standards
- Perform inspections to meet global safety requirements for product certification
- Collaborate in the design of new products, ensuring compliance
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Requirements (The Person)
Key Requirements
- Compliance Engineer
- Proficient in understanding and interpreting schematic diagrams
- Strong documentation and reporting skills
- Knowledge of regulatory requirements for Class I medical devices to MDD (Medical Device Directive) and MDR (Medical Device Regulation)
Preferred Experience & Competence
- Experience and competence in complying to:
- ISO9001 (Quality Management Systems)
- ISO13485 (Medical Devices Quality Management Systems)
- ISO14971 (Medical Devices - Application of Risk Management)
- Experience testing and complying to IEC60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
Additional Notes
Reference: BBBH25446H
Location Keywords: Cheltenham, Gloucestershire
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