13 of 13 DemandTrendPermanent ISO 13485 Jobs in London

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 ❯

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 ❯

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 ❯

that to be considered for this role you must have the right to work in this location. Responsibilities: Oversee and manage a quality management system (QMS) that complies with ISO 13485 standards. Handle document control, change management, corrective actions, training records, audits, and supplier oversight. Lead internal and external audits, ensuring systems are always ready for inspection. Develop … marking, MHRA Class I-II, FDA registration, and 510(k) processes. Maintain technical files and coordinate cross-functional inputs to meet regulatory deadlines. Key Skills and Requirements: Experience managing ISO 13485-compliant QMS and leading audits. Familiarity with Software as a Medical Device (SaMD) is essential. Strong knowledge of UKCA, MHRA, FDA regulations, and cybersecurity standards such as More ❯

that to be considered for this role you must have the right to work in this location. Responsibilities: Oversee and manage a quality management system (QMS) that complies with ISO 13485 standards. Handle document control, change management, corrective actions, training records, audits, and supplier oversight. Lead internal and external audits, ensuring systems are always ready for inspection. Develop … marking, MHRA Class I-II, FDA registration, and 510(k) processes. Maintain technical files and coordinate cross-functional inputs to meet regulatory deadlines. Key Skills and Requirements: Experience managing ISO 13485-compliant QMS and leading audits. Familiarity with Software as a Medical Device (SaMD) is essential. Strong knowledge of UKCA, MHRA, FDA regulations, and cybersecurity standards such as More ❯

engineering governance activities, including Critical Design Reviews (CDRs). Collaborate with verification and validation teams to support defect triage and resolution. Monitor regulatory standards, ensuring compliance with IEC 60601, ISO 14971, and other relevant frameworks. Conduct risk management activities, including FMEA, hazard analysis, and early-phase risk reviews. Provide technical input, risk assessments, and continuous improvement recommendations during project … s degree (or equivalent) in Biomedical, Mechanical, Electrical, Systems Engineering, or related discipline. Proven problem-solving skills in high-reliability, life-supporting systems (e.g., ventilators). Demonstrated experience applying ISO 14971 risk management to medical device development. Strong knowledge of IEC 60601-1 standards for safety and performance in medical systems. Background in systems engineering disciplines: requirements management, architecture … V&V, and release. Proficiency in requirements engineering and risk analysis techniques across the device lifecycle. Strong understanding of ISO/IEC/IEEE 15288 systems engineering lifecycle within regulated environments. Experience working cross-functionally in multidisciplinary teams. Desirable Skills Experience in R&D within regulated industries, ideally under ISO 13485 and IEC 60601. Knowledge of real 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 ❯

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 ❯

and external stakeholders. Good communication skills. Collaborative and willing to listen to others ideas. Technical knowledge (platform/backend) is advantageous 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 ❯

Lakes and Data Warehouses; create robust data transformation processes that ensure data quality, consistency and security and implement automation workflows. You will help to maintain compliance with ISO27001 and ISO13485 requirements for healthcare data management and ensure that security first practices are employed in all data processing solutions to protect sensitive patient information. This is a great opportunity to join … working with sensitive patient data You have a strong understanding of healthcare data standards (HL7, FHIR, OMOP, SNOMED) and data modelling; as well as healthcare technology and regulatory requirements (ISO13485, ISO27001) You have experience of managing data in Azure using tools such as Azure Data Factory, Azure Databricks, Azure Synapse Analytics You have a good knowledge of Data Lake and More ❯

experience is preferable Content/copywriting would be highly advantageous Please attach a link or upload your portfolio with your application 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 ❯