15 of 15 ISO 13485 Jobs in England

scaling digital health organisation. Key Responsibilities Quality & Regulatory Leadership Own and maintain the organisation’s Quality Management System (QMS) in line with ISO 13485 Act as the internal lead for the ISO 27001 Information Security Management System (ISMS) Ensure ongoing compliance with HIPAA, DTAC, NHS DSP Toolkit … practical guidance for non-specialist stakeholders Support leadership with compliance reporting and customer or partner due diligence Key Authorities Authority to coordinate and maintain ISO 13485 and ISO 27001 management systems Authority to coordinate evidence and submissions for DTAC, NHS DSP Toolkit, and Cyber Essentials Plus Authority ...

Conduct code reviews, debugging, and optimisation with a focus on performance and power efficiency. Apply regulatory standards and software development lifecycle processes (IEC 62304, ISO 13485) throughout the project. Collaborate with hardware engineers to interpret schematics and datasheets. Produce and maintain technical documentation, including software requirements, design specifications … microcontrollers and associated toolchains (GCC, CMake, etc.). Proficient with RTOS environments such as FreeRTOS or Zephyr. Experience working within regulated industry (IEC 62304, ISO 13485). Proficient with version control (Git) and hardware debugging tools (oscilloscopes, logic analysers). Comfortable working autonomously. Nice-to-Have: Experience with ...

transition into medical technology Medical device or regulated industry specialists Embedded software engineers with experience in medical devices or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, or similar sectors Package & Benefits £60,000 - £70,000 base salary (DOE) Generous employer pension contribution … consider applicants from three backgrounds: Medical device specialists, experienced embedded software engineers with a background in medical, healthcare, or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, and similar sectors Regulated industry engineers, with transferrable skills from other safety critical or regulated sectors ...

embedded/firmware literacy Hands-on engineering mindset Experience in regulated or process-heavy industries (Medical devices, aerospace, automotive, nuclear, oil & gas) Exposure to ISO frameworks (ISO 13485 is a plus but not essential) Methodical, structured, documentation-first mindset Strong communicator and growth-oriented ...

teams to support defect triage, issue resolution, and validation. Monitor regulatory changes and ensure compliance with standards such as IEC 60601 and ISO 14971. Conduct risk management activities including FMEA and hazard analysis. Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications Essential: Bachelors degree in biomedical … mechanical, electrical, or systems engineering (or equivalent). Strong background in high-reliability systems (e.g., ventilators). Deep understanding of ISO 14971 and IEC 60601-1 standards. Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release. Familiarity with ISO/IEC/IEEE ...

following would be a bonus: Skills in containerisation/orchestration (Docker, Kubernetes etc.); IaC; DynamoDB; Spring Boot and Gradle; knowledge of standards such as ISO 13485 or IEC 62304. This role is predominantly remote, with occasional attendance of the company's London office - you will therefore need ...

products - Lead the full hardware development lifecycle including requirements, design, prototyping, testing, debugging and production support - Ensure compliance with regulatory standards (e.g., IEC 60601, ISO 13485) - Conduct EMC testing and troubleshoot hardware issues - Collaborate with cross-functional teams to deliver integrated solutions - Maintain accurate documentation and stay current ...

industries Degree and 8+ years of commercial experience Desirable Experience Experience working in a consultancy or project-based environment Compliance standards (e.g., IEC 62304, ISO 13485) Background in the medical, pharmaceutical, or healthcare industries Please note we cannot provide sponsorship for this role. If you are interested ...

industries Degree and 8+ years of commercial experience Desirable Experience Experience working in a consultancy or project-based environment Compliance standards (e.g., IEC 62304, ISO 13485) Background in the medical, pharmaceutical, or healthcare industries Please note we cannot provide sponsorship for this role. If you are interested ...

Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person ...

development Collaborate with external vendors/suppliers Support documentation required for testing You will bring the following Hands on software engineering within a ISO13485 environment Experience in full stack development across Azure Previous background in web and and cloud technologies BSc or MSc in a relevant Life Sciences subject ...

architect strategies Line management of a small team You will bring the following Hands on software engineering within medical devices with standard experience win ISO13485 and IEC62304 Prior experience as an Architect Full stack experience with IoT, cloud, web for both frontend and backend Previous track record of working across ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...

transition into medical technology Medical device or regulated industry specialists Embedded software engineers with experience in medical devices or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, or similar sectors Package & Benefits £60,000 – £70,000 base salary (DOE) Generous employer pension contribution ...

required. Required to learn, understand, and apply relevant legislation, national standards, professional and other guidelines e.g. ISO 9001(2015) Radiotherapy Quality System, ISO13485, Medical Devices Directive 93/42/EEC, Data Protection Act, Caldicott and other relevant standards Requirement for frequent working out of clinical hours to minimize … maintain proper records of all work carried out on the radiotherapy equipment Operate, maintain and develop procedures for the identified system(s) within the ISO 9001-2015 Quality System to ensure system(s) and procedures are fit for clinical use. To prepare reports and to analyse and present complex ...