20 of 20 ISO 13485 Jobs in the UK excluding London

contribute to the success of a leading medical device company, we want to hear from you! Key Responsibilities: Assist in maintaining compliance with certifications and regulatory approvals such as ISO 27001, ISO 9001, ISO 13485, UKCA, CE, and FDA 510(k). Support the update and maintenance of QMS and ISMS documentation. Help coordinate and conduct … inclusive work environment. The Person Degree or equivalent qualification in Life Sciences, Quality Management, or a related field. 2+ years of relevant experience is preferred. A basic understanding of ISO standards or medical device regulations is desirable. Excellent organisational skills with strong attention to detail. Clear written and verbal communication abilities. A commitment to following procedures and maintaining accurate More ❯

scale) sourced from external manufacturers. Hands-on bring-up testing of assembled boards. Manufacture of wiring harnesses and integration of PCBs into hardware products. Identifying, evaluating, and testing external ISO 13485 accredited electronics assemblers and suppliers. Feeding back into the design process to improve manufacturability and performance. Working closely alongside other engineers in the team. Must-haves: Strong … with electronic circuit design. Familiarity with PCB design tools (KiCAD, EAGLE, Altium). Experience debugging circuits and interpreting assembly instructions. Layout experience on stripboard/matrix board. Awareness of ISO 13485 quality standards. Confident communicator who can explain technical concepts clearly. Why Apply? This is more than just an electronics assembly technician role - it's a chance to More ❯

scale) sourced from external manufacturers. Hands-on bring-up testing of assembled boards. Manufacture of wiring harnesses and integration of PCBs into hardware products. Identifying, evaluating, and testing external ISO 13485 accredited electronics assemblers and suppliers. Feeding back into the design process to improve manufacturability and performance. Working closely alongside other engineers in the team. Must-haves: Strong … with electronic circuit design. Familiarity with PCB design tools (KiCAD, EAGLE, Altium). Experience debugging circuits and interpreting assembly instructions. Layout experience on stripboard/matrix board. Awareness of ISO 13485 quality standards. Confident communicator who can explain technical concepts clearly. Why Apply? This is more than just an electronics assembly technician role - it's a chance to More ❯

a small company environment Strongly Advantageous: Experience in optoelectronics, PID temperature control, and reliability testing Expertise in IVD/medical device compliance (EU & USA) Experience in regulated product development (ISO 13485, IVDR, 60601, EMC standards, FDA approvals) If you're ready to make a real impact, apply today! How to apply for the role: If you have the More ❯

Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO 13485) is a plus. Desirable Experience in optical systems,ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯

Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO 13485) is a plus. Desirable Experience in optical systems,ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯

manufacturing). Proficiency with project management frameworks (Agile, Waterfall) and tools (e.g., MS Project, Jira, Confluence). Excellent client-facing and stakeholder management skills. Familiarity with regulated environments (e.g., ISO 13485, medical device directives) is highly desirable, though not essential. Project management certification (PMP, PRINCE2, Agile/Scrum) would be advantageous. Why Join? This is a career-defining More ❯

manufacturing). Proficiency with project management frameworks (Agile, Waterfall) and tools (e.g., MS Project, Jira, Confluence). Excellent client-facing and stakeholder management skills. Familiarity with regulated environments (e.g., ISO 13485, medical device directives) is highly desirable, though not essential. Project management certification (PMP, PRINCE2, Agile/Scrum) would be advantageous. Why Join? This is a career-defining More ❯

EKS). An understanding of Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

EKS). An understanding of Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

a mechanical/electrical mindset. Excellent communication and customer service skills. A proactive, independent worker who's flexible and travel-ready. Full UK driving licence (essential). Knowledge of ISO 13485/CE/UKCA quality standards is desirable but not essential. What's on Offer Competitive salary based on your skills and experience. Performance-based bonus scheme. More ❯

a mechanical/electrical mindset. Excellent communication and customer service skills. A proactive, independent worker who's flexible and travel-ready. Full UK driving licence (essential). Knowledge of ISO 13485/CE/UKCA quality standards is desirable but not essential. What's on Offer Competitive salary based on your skills and experience. Performance-based bonus scheme. More ❯

a mechanical/electrical mindset. Excellent communication and customer service skills. A proactive, independent worker who's flexible and travel-ready. Full UK driving licence (essential). Knowledge of ISO 13485/CE/UKCA quality standards is desirable but not essential. What's on Offer Competitive salary based on your skills and experience. Performance-based bonus scheme. More ❯

Some experience with containerisation and orchestration (Docker, ECS, or EKS) An understanding of Linux system administration (Ubuntu, Amazon Linux, etc.) Any experience of working within one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

Some experience with containerisation and orchestration (Docker, ECS, or EKS) An understanding of Linux system administration (Ubuntu, Amazon Linux, etc.) Any experience of working within one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

be working across engineering and R&D teams to support the design, integration, and commercialisation of semiconductor-based and biocomputing technologies. Your role will span product architecture, documentation to ISO 13485 standards, and hands-on delivery of systems that combine hardware, software, and biology. You'll collaborate with internal stakeholders and external partners to align technical execution with More ❯

improvement in patient outcomes. Your new role As QA Compliance Manager, you'll lead a team responsible for maintaining and improving the Quality Management System in line with GMP, ISO, and regulatory standards. Reporting to the Head of Quality, you'll oversee internal audits, batch record reviews, CAPA systems, and customer audits. You'll also contribute to strategic quality … discipline (e.g. Chemistry, Biology, or related field) Extensive experience in GMP-regulated environments (10+ years preferred) Strong leadership and people management skills In-depth knowledge of EU cGMP and ISO standards (9001, 13485) Experience supporting or conducting batch release under QP supervision Lead auditor training and a proactive approach to continuous improvement Excellent communication, organisational, and stakeholder engagement More ❯

supporting clinical trials and ensuring compliance with international standards. Key Responsibilities Define and document system architecture, design inputs, and interfaces. Lead risk management activities (FMEA, FTA) in compliance with ISO 14971. Maintain technical documentation (DHF) for audits and regulatory submissions. Manage system and sub-system requirements with full traceability. Support clinical investigations and verification testing. Collaborate with cross-functional … and regulatory. Drive process improvements and stay current with evolving standards. Skills & Experience Essential: Degree in engineering or a related field. Experience in regulated medical device development. Familiarity with ISO 14971 & ISO 13485. Strong understanding of system-level requirements and V&V principles. Desirable: Experience with implantable or active medical devices. Knowledge of IEC 60601, IEC 62304, or … ISO 14708. Proficiency with document control and requirements management tools. Experience working with clinical and academic partners. Whats on Offer Competitive salary based on experience. Private healthcare, income protection, life assurance. Company pension scheme. 27 days holiday plus bank holidays. Hybrid working. The opportunity to contribute to a transformative medical technology platform. More ❯

excellent benefits. Location: Cardiff Software Design Manager Responsibilities: Carry out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to More ❯

excellent benefits. Location: Cardiff Software Design Manager Responsibilities: Carry out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to More ❯