26 to 34 of 34 IEC 62304 Jobs in the UK excluding London

understanding QMS requirements. Engineering Excellence: Apply rigorous engineering practices, focusing on design reviews, decision-making, problem-solving, verification, risk management, and safety. Regulatory Compliance: Ensure adherence to standards like IEC 60601-1, IEC 60601-2-xx, IEC 62304, and necessary quality procedures for regulatory approvals. Cross-functional Collaboration: Foster relationships across R&D, PMO, product management … partners. Proven leadership in embedded Linux software and firmware development, preferably in medical devices. Experience with embedded electronic/software systems, communication technologies, software design, APIs, quality standards like IEC 62304. Background in product development within ISO 14971 quality systems, including approvals for EU-MDD, EU-MDR, and FDA. Flexible, adaptable, and capable of guiding teams through change in … a dynamic environment. Excellent communication skills, able to present to diverse stakeholders. Desirable Knowledge of IEC 60601 and AAMI EC standards for medical devices. What We Offer A challenging, innovative environment with competitive benefits tailored to your preferences. We value health, well-being, and personal growth, offering flexible schedules and health activities. #LI-EU #LI-Office #J-18808-Ljbffr More ❯

to design reviews, decision-making, problem solving and verification testing, with a strong focus on risk management and safety. Regulatory Compliance : Ensure adherence to relevant medical device standards (e.g., IEC 60601-1, IEC 60601-2-xx, IEC 62304) and quality procedures necessary for regulatory approvals. Cross-functional Collaboration : Foster strong working relationships across R&D, PMO … environment You are experienced in embedded electronic/software systems (including comms technologies like TCP/IP, ethernet, USB, WiFi, Bluetooth), software design, object-orientated design, APIs, software quality, IEC 62304. You have worked in product development within an ISO 14971 quality system (preferably including experience of product approvals for EU-MDD, EU-MDR and FDA). You have … your team through working within a dynamic environment You are a clear and concise communicator, with the ability to present to a broad range of stakeholders Desirable: Knowledge of IEC 60601 and AAMI EC medical device standards. In return, we offer you a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and More ❯

in an IVD environment along with practical experience in working to applicable management standards (i.e. ISO 13485). Experience with and demonstrable understanding of some of the following: IEC14971, IEC 62304, IEC 62366, GLP, EMC (IEC61326), IEC61010-1, packaging/transport standards, labelling standards and IVDR performance evaluation requirements Desirable: Experience of leading (from the manufacturer side More ❯

GTK, and CMake. Experience in designing and implementing graphical user interfaces. Competence in writing well-tested and testable code. Understanding of software development in regulated industries, especially medical (e.g., IEC 62304 compliance). Strong communication skills, with the ability to explain technical concepts to non-technical stakeholders. Capable of working independently, prioritising tasks, and meeting project deadlines. Willingness More ❯

and manage the product backlog, Mentoring and supporting the development team with technical challenges, Managing milestone planning and ensuring timely delivery of software, Ensuring development follows ISO 13485 and IEC 62304 processes for clinical software. We require: Proven experience as a Technical Project Manager, especially in software development Strong expertise in Angular front-end development Solid experience with … Agile methodologies Proficiency in English, Polish is welcomed, Knowledge of ISO 13485 and IEC 62304 standards for clinical software, Excellent communication skills and experience leading teams, Ability to manage multiple priorities in a dynamic, fast-paced environment, Willingness to visit client’s office in Warsaw once or twice a month. We can offer: Attractive salary: Competitive pay reflecting More ❯

US market entry. Documentation & Submissions: Prepare and maintain regulatory submissions and documentation including Declarations of Conformity, Technical Files and labelling reviews. Ensure documentation is in compliance with ISO 13485, IEC 62304, ISO 14971, and other applicable standards. Risk Management: Lead and coordinate risk management activities in accordance with ISO 14971, integrating risk assessments throughout the product development and … for improving lives through assistive technology. Strong working knowledge of UK MDR, EU MDR, and FDA medical device regulations. Familiarity with technical standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series. Experience with Class I medical devices and SaMD regulatory requirements. Excellent documentation and communication skills – able to communicate clearly and concisely in More ❯

and CAPA activities, with a solid understanding of QMS. Engineering Excellence: Apply rigorous engineering practices focusing on risk management and safety. Regulatory Compliance: Ensure adherence to relevant standards like IEC 60601-1, IEC 60601-2-xx, IEC 62304, and quality procedures for regulatory approvals. Cross-functional Collaboration: Foster relationships across R&D, PMO, product management, operations … collaboration with partners. Proven experience leading software and firmware development in embedded Linux, preferably in medical devices. Knowledge of embedded electronic/software systems, communication technologies, software design, APIs, IEC 62304. Experience within an ISO 14971 quality system, including product approvals for EU-MDD, EU-MDR, and FDA. Flexible attitude, capable of guiding teams through dynamic environments. Clear and … concise communication skills for stakeholder presentations. Desirable Knowledge of IEC 60601 and AAMI EC standards for medical devices. What We Offer A challenging, innovative environment with competitive benefits tailored to your preferences. We value health, well-being, and personal growth, offering flexible schedules and local health activities. #LI-EU #LI-Office #J-18808-Ljbffr More ❯

CD pipelines (GitLab preferred) Strong communication skills and experience working in agile teams Understanding of AI as a Medical Device (AIaMD) development and relevant regulations (EU MDR, FDA, ISO 62304, ISO 14971, ISO 34971) Comfortable working with Linux-based systems Experience with Django Knowledge of SQL and database schema design Exposure to Next.js/TypeScript (beneficial but not essential More ❯

England, United Kingdom 1 week ago BUILDING SERVICES - Junior Mechanical Project Manager Winnersh, England, United Kingdom 3 months ago Remote Senior Risk Management Engineer, Medical Devices (ISO 14971/IEC 60601/IEC 62304) 12 months Fixed Term contract bei Vision RT Surrey, England, United Kingdom 1 month ago We’re unlocking community knowledge in a new More ❯