1 to 25 of 92 ISO 13485 Jobs in the UK

Manufacturers. Your responsibilities: Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit processes Be involved in maintaining … equivalent Work experience - Minimum of four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc. … demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO 27001 Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information Ferociously curious - You like going down rabbit holes, understanding More ❯

you must be able to attend the Trust Hospital site in person** Main duties of the job The Quality & Information System Manager is responsible for the Clinical Engineering Department ISO registration and ongoing compliance as well as the databases used within Clinical Engineering. Responsible also for co-ordinating the training programmes for ISO and databases for all clinical … on one of the Trust sites Mon-Fri, with the occasional service need to work out of hours.o To maintain comprehensive training records for clinical engineering personnel relating to ISO and the databases.o To organise and co-ordinate internal/external training programmes for clinical engineering personnel.o To assist the senior management team in maintaining the departments database and … ISO 13485 Quality Management System (QMS) ensuring all associated paperwork is maintained and current.o Main site of work is at University Hospital Lewisham, but the post holder may also be required to start work on any site used by the Trust. Travel between sites may be required within a working day, for example to travel between University Hospital More ❯

and strategically minded RA/QA Senior Specialist with deep expertise in Software as a Medical Device (SaMD) and artificial intelligence (AI) regulatory frameworks, including the EU AI Act, ISO/IEC DIS 42001 (AI Management System), ISO/IEC 23894 (AI Risk Management), BS 30440:2023 (Validation framework for AI in healthcare), and MHRA guidance on Software … environment, ensuring alignment with evolving global standards and supporting innovation in regulated software development. Provide strategic oversight for interpreting and implementing regulatory frameworks such as the EU AI Act, ISO/IEC DIS 42001, ISO/IEC 23894, BS 30440:2023, ensuring comprehensive alignment with ethical, technical, and compliance considerations specific to AI and LLM applications in SaMD. … translating complex regulations into clear, strategic actions for cross-functional teams. Software Development Lifecycle: Provide strategic leadership over the software development and release management process, ensuring comprehensive compliance with ISO 62304 and ISO 13485. Collaborate closely with engineering leadership to ensure that software modifications and updates adhere rigorously to regulatory and quality expectations before approval and deployment. Lead More ❯

s revolutionising medical diagnostics and transforming patient care. Key Responsibilities Oversee and develop our medical device Quality Management System (QMS) and Information Security Management System (ISMS), ensuring compliance with ISO 13485, MDSAP, US FDA QSR, EU MDR and ISO 27001. Implement and secure certification for an Artificial Intelligence Management System in line with ISO 42001 and … or related field. Minimum 5 years of hands-on QMS management experience in medical devices, preferably with AI/Software as a Medical Device (SaMD) products. Demonstrable expertise in ISO 13485, EU MDR and FDA QSR (21 CFR 820) quality system requirements. Proven track record supporting external audits (notified body, FDA inspections). Experience leading significant management system … changes and improvements. Strong analytical and problem-solving skills, with ability to find pragmatic and creative solutions. Certification as a Lead Auditor (ISO 13485) and/or Certified Quality Auditor (CQA) is a plus. Competitive salary Share options package - all our employees have ownership in the company Private healthcare 25 days annual leave (+ company shut down in More ❯

Engineer. In this role you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for the maintenance of the quality system to ISO 13485 standards and associated product certification. As a Quality Systems Engineer, you will: Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management … audits. Analyse quality data and contribute to process improvement initiatives. Required experience: 2+ years of experience in a Quality role within the medical device industry Hands-on knowledge of ISO 13485 and 21 CFR 820 Strong attention to detail and problem solving skills Ability to work as part of a multi-disciplinary, fast-paced diverse team Ability to More ❯

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. More ❯

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. More ❯

to the wider company. Awareness of the sensitive nature of our data - following our data protection guidelines. Being fully aware of our ways of working - within our regulatory standards (ISO 13485, ISO 27001). ️ We want to hear from you if you Have experience in the following tech stack: Frontend: React, State Management, React Native (optional but … with Publish-Subscribe pattern Experience of working with Jira, BitBucket and Git Experience in working within a regulated SDLC process (optional but advantageous) Experience in working in MedTech, including ISO 62304 (optional but advantageous) Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality More ❯

manage a career development framework. Own IEC 62304 traceability, architecture documentation, and release quality for critical features and audits. Establish agile delivery practices that work within the constraints of ISO 13485 and MDR/FDA expectations. Introduce best engineering & delivery practices, improve and and report on velocity, release cadence, defect rate, and other metrics. Champion continuous improvement - lead … paced, regulated medical or AI-based software environment, having delivered multiple health tech products Building and delivering clinical software products with end-to-end traceability under IEC 62304 and ISO 13485 Driving complex technical decision-making (e.g., architecture reviews, release criteria) Leading or supporting regulatory audits and inspections Managing stakeholders across Engineering, Product, QA, and Compliance Implementing metrics … team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

UK. Job description Job responsibilities DUTIES AND RESPONSIBILITIES General Ensure all work complies with current UK legislation for work with ionising radiation (IRR 2017, IRMER 2017) and the Trusts ISO 9K2K-compliant quality management system for provision of radiotherapy. The post holder will be expected to prioritise and manage their own work on a day-to-day basis. The … Knowledge Essential oKnowledge of radiotherapy physics oUnderstanding of the role of computational systems in radiotherapy oKnowledge of relevant legislation, national standards, and professional guidelines (e.g. IRR'99, IRMER 2000, ISO:9K2K, ISO 13485, ISO 14971, IPEM Codes of Practice, GDPR, Data Protection Act) Desirable oTheoretical Machine Learning/AI and statistics knowledge oUnderstanding of principles of More ❯

working with the Lead to align on deliverables and be key in delivering to multiple business units. Being fully aware of our ways of working - within our regulatory standards (ISO 13485, ISO 27001). ️ We want to hear from you if you Have experience in the following tech stack: Backend: Nodejs, JavaScript, Express Frontend: React, (optional but … and HL7 Ability to deal with internal and external stakeholders. Good communication skills. Collaborative and willing to listen to others ideas. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

procedures, identify instrument/component performance, ensuring all observations and data are recorded. Analysing results and experimental data to determine pass/fail. All activity to comply to ISO9001 & ISO 13485 (cGMP) Responsible to the Maldi Test Manager for: Final test of MALDI TOF instrument systems, checking their performance for reliability and specification levels under a various conditions. … team measures, facilitating and driving continuous improvements. When required, train new engineers and peers. Correct use of tools and processes, described in SAMI's & Test procedures. Comply to ISO9001 & ISO 13485 (cGMP) If required Commissioning of instruments within the U.K. and R.O.W. territories Qualifications (E/D): Degree/HND science/engineering basis; Chemistry, Physics, Biological, Electronics More ❯

STM32). Familiarity with RTOS, bare-metal, or embedded Linux environments. Professional experience utilising Docker containers. Experience with communication protocols (UART, SPI, I2C, USB). Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820. Strong understanding of software development lifecycle and version control (e.g., Git). Qualifications Bachelor's or Master's degree in computer More ❯

through certification under UK MDR You're highly self-starting, proactive, and comfortable working autonomously You have deep knowledge of UK MDR and strong working familiarity with IEC 62304, ISO 14971, and ISO 13485 You've worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development You're More ❯

work as part of a multi-disciplinary team DESIRABLE REQUIREMENTS: Use of schematic capture software Circuit analysis experience Knowledge of simulation packages Mathematical analysis skills Experience working within an ISO13485 or similar quality system Experience following IEC 62304 or similar Development of test harnesses and tools using C#/.NET. More ❯

tools and environment. Suggests changes to current Optos systems to improve efficiency and quality of software development. All activities to be carried out in compliance with the Optos SDLC, ISO13485 and FDA Medical Device Design Control processes. MINIMUM QUALIFICATIONS Educated to degree level in a software engineering discipline or equivalent education gained through work experience. 5+ years' experience in designing More ❯

embedded, application, and UI layers. Own our full software stack - from real-time firmware to intuitive user interfaces. Introduce lean, agile development practices within a regulated framework (IEC 62304, ISO 13485). Build for extensibility - enabling third-party instrument development and open platform integrations. Collaborate cross-functionally with hardware, UX, clinical, regulatory, and quality teams. Manage and mentor … track record delivering full-stack systems, including RTOS-based firmware and application software. Deep knowledge of modular, scalable platform architecture. Strong grasp of compliance standards like IEC 62304 and ISO 13485. Excellent communication, problem-solving, and team-building skills. Experience leading teams and delivering in dynamic, mission-driven environments. Your Background: Degree-qualified in software engineering, computer science, electrical … engineering, or related discipline. Bonus points for direct experience with IEC 62304 or ISO 13485. Willingness to travel occasionally for labs or customer collaboration. Why Join Us? This is a rare opportunity to own the software backbone of a system with global clinical impact. At Creo, you'll help define the digital infrastructure powering the future of surgery - with More ❯

cryptographically protected communication channels Knowledge about implementation of BLE systems for secure and robust communications Experience developing embedded systems for early-stage medical devices under IEC 60601, 62304, and ISO 13485 Notice By submitting your application, you acknowledge that Motif Neurotech will process your personal data for recruitment purposes. This includes evaluating your qualifications, contacting you regarding the More ❯

SQL Experience working with data lakes, warehouses, and large-scale datasets Understanding of data privacy and security principles Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts More ❯

team of engineers across multiple disciplines (mechanical, electrical, software, systems) Oversee the design, development, testing, and validation of innovative medical devices in accordance with regulatory standards (e.g. FDA, CE, ISO 13485) Drive project execution, ensuring timely delivery, budget adherence, and product quality. Collaborate cross-functionally with R&D, Quality, Regulatory, and Project teams to align engineering efforts with More ❯

maintaining a strong focus on customer satisfaction. Maintain organised records and ensure all documentation is archived in line with company policies. Follow all relevant procedures and quality standards, including ISO13485, ISO14001, and Medical Device Regulations. Engage in continuous improvement by completing all required training and Learning Management System (LMS) modules on time. Qualifications and Experience: Must be educated to a … at least 2 years' proven experience in a similar role. Excellent communication skills (written and verbal). Experience with SAP and Salesforce is highly desirable. Experience working in an ISO 13485 , 14001 and MDR regulated environment is desirable. Skills: IT Skills including the ability to use Microsoft Office at a proficient level. Good English in verbal and written More ❯

pragmatic, can-do attitude Comfortable working across teams in a fast-moving, multidisciplinary environment Well-organised, detail-oriented, and driven to see complex projects through to completion Experience with ISO 13485 or similar regulated manufacturing is a big plus Who you'll work with: Our Director of Cartridge Manufacturing and Programme Managers Cross functional teams including engineers, technicians More ❯

Requirements: 2 3 years experience in sales or business development within electronics Demonstrable success in driving new business Excellent communication and negotiation skills Familiarity with ISO9001 and/or ISO13485 Full UK driving licence Ability to travel to East Kent 3 times per week Looking for a role where you can make a real impact? Apply now. Morgan Jones is More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯