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 … ISO13485 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 ISO13485, 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 ISO13485, 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 (ISO13485) 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 ❯
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 ISO13485 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 ISO13485 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 ❯
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 ISO13485 You've worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development You're More ❯
trend analysis, clinical evaluation reports including literature search, post market clinical follow-up studies, and vigilance reporting. Regulatory & Medical Device Compliance Support compliance with UK MDR, EU MDR, and ISO standards (e.g., ISO13485). Contribute to the preparation of regulatory submissions and audits by providing clinical evidence and safety documentation. Participate in internal and external audits 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., ISO13485, FDA guidelines) is highly preferred. More ❯
City of London, London, United Kingdom Hybrid / WFH Options
Oho Group Ltd
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., ISO13485, FDA guidelines) is highly preferred. 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 ISO13485 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 ISO13485 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 ISO13485 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 ❯
skills * Great attention to detail and a results driven approach * Excellent organizational and leadership abilities * Reliable and Trustworthy * Certification of quality control is a strong advantage (ISO 9001, ISO13485 etc.) Please send your CV to me, Martin Warner, and I will get back to you as soon as possible 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 ❯
