1 to 25 of 41 ISO 13485 Jobs in England

subsystem architects and external partners, while managing technical debt and prioritizing customer-centric non-functional requirements. Ensure software compliance with medical regulatory standards like FDA, MDR, IEC 62304 and ISO 13485.Maintain comprehensive documentation to support regulatory submissions, audits, and compliance reviews. Collaborate with global R&D teams and stakeholders in marketing, PMO, quality, regulatory, and service functions.Serve as a … teams in multiple product launches. Your skills include a strong background in clinical applications, systems integration, interoperability, and knowledge of medical device regulations like IEC 62304, FDA, MDR, and ISO 13485.You are familiar to work in agile development methodologies like SAFe, apply AI/ML technologies, and are able to solve problems using modern C++ code. You have a More ❯

level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

or related field (or equivalent work experience). Previous experience in a fast-paced PCB fabrication environment required. Familiarity with quality systems such as ISO 9001, AS9100 or ISO13485 is a plus. If you are passionate about leading teams in a dynamic environment and possess the necessary skills, we encourage you to apply for this exciting opportunity as a 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 ❯

product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯

product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯

Electronic Medical Records (EMR)solution called Clinicalvision, designed specifically for the renal market and the management of clinical records for CKD, ESRD and transplant patients. Clinical Computing is an ISO 13485 Medical Device certified organisation. Clinical Computing along with Mediqal H.I., its sister company in the UK, are both members of the Constellation Kidney Group. Key Responsibilities Create … also be familiar with help desk software. Ultimately, you will help maintain our reputation as a company that offers excellent customer support. Responsibilities Undertake activities in accordance with our ISO 13485 Medical Device Quality Management System. Diagnose and troubleshoot technical issues. Ask customers targeted questions to quickly understand the root of the problem. Track computer system issues through More ❯

My client is a leading AS9100 and ISO 13485 accredited UK contract electronics manufacturer with over 30 years' experience based in Luton, Bedfordshire. They work within a range of industry sectors with vastly experienced and qualified staff offering tailored bespoke solutions to all their clients. Why Join? They have a total of 100 staff members across the UK 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 ❯

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 ❯

Description Job Posting Description In this role, you have the opportunity to Be involved in the development of Philips CDS software, within the Tools team. In compliance with the ISO standards applied to the medical sector (ISO 13485), you will participate in the creation of tools used by our development teams. You will propose a technical design … inclusion here . Rattaché au responsable du développement, vous intervenez sur le développement des logiciels de Capsule Technologie au sein de l'équipe Tools. Dans le respect des normes ISO appliquées au médical (ISO 13485), vous participerez à la réalisation des outils utilisés par nos équipes de développement. Vous proposez un design technique, vous écrivez le code More ❯

and product validation, iterating based on test results and feedback. Collaborate with suppliers on design reviews, ensuring cost-effective, reliable manufacturing. Ensure compliance with relevant regulatory and quality standards (ISO 9001, CE, RoHS, EMC considerations). Support root cause analysis and continuous improvement (CI) activities during and post NPI. Document processes and design changes, maintaining alignment with engineering change … understanding of DFM/DFA principles. Ability to work closely with cross-functional teams (electronics, firmware, quality, production). Experience in risk assessment, FMEA, and quality documentation aligned with ISO 9001 or similar. Comfort with prototyping, debugging, and iterative design. Nice to Have Experience in RFID/NFC, barcode scanners, or imaging devices mechanical design. Familiarity with ISO 13485, ISO 14971, or similar regulated environments. Exposure to Lean Manufacturing, Six Sigma methodologies. Experience designing test fixtures for production and QA. Familiarity with IP rating considerations for rugged devices. Why us? Work on real hardware products that ship globally. See your designs in use in airports, banks, and secure environments worldwide. Join a collaborative, engineering-led 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 ❯

in Python and ML frameworks such as PyTorch or TensorFlow Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485 Experience with MLOps practices and model versioning in compliant environments Preferred Qualifications: Experience building ML models with wearable data (e.g., continuous heart rate, motion, respiration) Exposure to 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 ❯

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 ❯

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 ❯

to work in the UK Genedrive is a pioneering medical device company headquartered in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC 62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a … Degree-qualified in a science or engineering discipline Minimum 3 years of experience in a QA/RA role within the IVD or medical device sector Solid understanding of ISO 13485 and ISO 14971 Experience with internal/external audits and training delivery Excellent analytical, organisational, and communication skills Comfortable working independently and within cross-functional teams … Desirable: Knowledge of IEC 62304, ISO 60601, and global radio regulations Experience with global medical device regulations particularly UK, EU and USA Familiarity with the commercialisation of IVD products ISO 13485:2016 Lead Auditor training This role is a unique chance to step into a high-impact position within a fast-moving and rewarding sector, apply now 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 ❯

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 ❯

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 ❯

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 ❯