1 to 25 of 165 ISO 13485 Jobs in the UK

Cycle (SDLC) for both products and internal tools Verification and Validation: Lead formal Software Verification and Validation (V&V) activities, ensuring adherence to industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO 13485, and FDA regulations, including cybersecurity requirements Process Improvement: Drive continuous improvement by enhancing automation, adopting innovative testing techniques, and optimizing testing processes More ❯

Regulatory team, to develop safe and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, IEC 13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross-functional development activities, ensuring adherence to all phases of More ❯

reusable code from general requirements. Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc) Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least 3-5 years of industrial experience in 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 ❯

with evolving priorities Ability to work effectively either as part of an interdisciplinary team or independently to deliver against agreed timescales and outputs Experience working to strict quality standards (ISO13485) is desired, but not required. #J-18808-Ljbffr More ❯

to the relevant health care authorities. To ensure that products conform with relevant regulations in territories in which they are sold; OND and ONT operate two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT). Reporting and providing primary support to the Head of QA, the role of the Associate Director Quality Assurance is responsible for … representing the Head of QA (as directed) in any matter. • All activities required to help ensure the QA team achieve their annual objectives and maintain/sustain the ISO9001 & 13485 accreditation. This may require the role to fulfill part of the role of "Person with Responsibility for Regulatory Compliance" as per the EU IVDR. • Establish strong working relationships across … challenging health authority interactions is highly desired. Understanding or experience of computer systems validation is desirable (e.g. GAMP5). Knowledge/Skills/Abilities Essential: Detailed working knowledge of ISO13485, MDSAP requirements and the IVDR are essential. Demonstrable experience of working with external partners and stakeholders, showing a balanced level of discretion and sensitivity to both risk and commercial interests 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 ❯

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. #J-18808-Ljbffr More ❯

experience developing complex software or electromechanical medical devices • Excellent understanding of design controls and good documentation practices • Experience in applying regulatory standards to products (IEC 60601, 14971, 62366, 62304, ISO 13485 or aerospace equivalents) • Willingness to be on-site (minimum 2 -3 days/week in London office) Nice to Haves • Experience with wireless communications systems, modern digital More ❯

and energy harvesting technologies. Wearable Prototyping : Hands-on experience with miniaturization, waterproofing, and creating robust electronics for wearable devices. MedTech Regulatory Standards : Knowledge of medical device regulatory standards (e.g., ISO 13485, FDA) and experience in compliance testing. Sensor Integration : Familiarity with various biosensor technologies, including electrochemical sensors used in wearable health devices. Wearable Data Transmission : Practical experience in More ❯

environments in Azure, focusing on Web Apps and Functions Implement logging, monitoring, and alerting solutions for security events and system health Automate compliance checks and documentation for ISO27001 and ISO13485 requirements Collaborate with development teams to implement security best practices and DevSecOps processes Manage and maintain security protocols for handling sensitive healthcare data Required Qualifications: Strong experience with Infrastructure as … scanning (Snyk, SonarQube) Experience of Azure Web Apps and Azure Functions Deep understanding of cloud security best practices and implementing Zero Trust architecture Experience with healthcare compliance requirements (ISO27001, ISO13485, HIPAA) and security controls Proven track record implementing automated security testing and vulnerability management Strong knowledge of monitoring and observability tools (Azure Monitor, Application Insights) Experience implementing secure networking and More ❯

includes clinical, veterinary, environmental testing, and research customers. Whether working on a research use only or regulated assay, you will ensure that our product design and maintenance meets our ISO13485 and ISO9001 quality management system requirements and that software meets the required standards. You will support our genomics services and product development functions building analysis pipelines for a range of … compliance with all applicable regulatory standards. Provide expert technical support for customers when required. Ensure the completion of research-related documentation (including technical summaries) in line with our ISO15189, ISO13485, and ISO9001 quality management systems. Supervise and mentor junior team members. Qualifications, Skills, and Abilities: MSc in Bioinformatics, Computational Biology, Genomics, or Biological Science with 5+ years of direct bioinformatics … in writing bioinformatics pipelines for NGS data analysis and experience in analysing large datasets. Experience of working within a quality system in a regulated industry is highly advantageous, particularly ISO13485, ISO9001 and/or ISO15189. Experience in statistical analysis of data and a range of statistical packages. Demonstrated experience to lead and deliver complex projects on time. Closing Date: Sunday More ❯

development of the Business Management System and associated platform, as a phased improvement in accordance with business requirements. Lead by example on good documentation practice and other elements of ISO 9001, AS 9100, ISO 13485 and other standards as applicable. Conduct document control activities in accordance with business requirements. Support the production of new business management system … of direct involvement in quality management in an industrial manufacturing and product development setting, preferably in the medical, automotive, aeronautics and/or space industry. Knowledgeable regarding ISO9001/ISO13485/AS 9100/ISO 14001 and other relevant standards. Strong interpersonal skills and the ability to work well with external bodies, customers, suppliers and all internal teams at … and problem-solving skills. Proficient in the use of Microsoft Office Packages (Excel, Word, PowerPoint). Qualification and at least three years’ experience of internal auditing to either ISO9001, ISO13485 or AS 9100 and other relevant standards. A Bachelors’ degree from a university of applied sciences, preferable in Electrical or Mechanical Engineering or equivalent Practical knowledge of electronics engineering. I More ❯

Manufacturers. Your responsibilities: Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit processes Be involved in maintaining … equivalent Work experience - Minimum of four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc. … demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO 27001 Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information Ferociously curious - You like going down rabbit holes, understanding More ❯

Manufacturers. Your responsibilities: Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit processes Be involved in maintaining … equivalent Work experience - Minimum of four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc. … demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO 27001 Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information Ferociously curious - You like going down rabbit holes, understanding More ❯

You will be required to support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with EU GDP guidelines. Ideally you will have experience of working in a GMDP environment. We are looking for … QA & RA, QA Managers, Responsible Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards. Supporting the ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures. Promoting a positive Quality culture … within the organisation. Supporting Quality System Management Reviews, including the preparation of meeting inputs, attendance and presentation at meetings and the management of the meetings outputs. Supporting Regulatory, ISO and Client audits, and conducting Supplier audits, internal audits, and self inspections, including the preparation of responses and CAPA plans. Key Skills/Experience/Requirements: Strong organisational and communication More ❯

regulatory standards. QARA Software Specialist Location: London (on-site 4 days/week) Salary: Dependent on experience + benefits Responsibilities Develop, implement, and maintain software QA processes compliant with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification activities, including test planning, execution, and documentation. Collaborate with software engineers to … ensure SDLC compliance, including risk management (ISO 14971) and cybersecurity. Support regulatory submissions by preparing documentation such as Software Development Plans, DHF, and SBOM. Address and document non-conformances, CAPAs, and audits related to software. Skills & Experience Experience in QA/RA for medical device software or related fields. Strong knowledge of ISO 13485, IEC 62304, FDA … CFR Part 820, and EU MDR regulations. Experience with software validation, V&V testing, and risk management (ISO 14971). Familiarity with configuration management, cybersecurity standards, and AI/ML regulations is a plus. Hands-on with document control systems (e.g., eQMS), CAPA, and audits. Analytical, detail-oriented, with excellent communication skills to translate regulatory requirements into engineering processes. More ❯

role in ensuring the software in our medical technology meets the highest quality and regulatory standards. Responsibilities: Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification (V&V) activities, including test planning, execution, and documentation. Collaborate with software … engineers to ensure software development lifecycle (SDLC) compliance, including risk management (ISO 14971) and cybersecurity considerations. Support regulatory submissions (e.g., FDA 510(k), CE marking) by preparing software-related documentation such as Software Development Plans, Software Design History Files (DHF), and Software Bill of Materials (SBOM). Ensure that non-conformances, CAPAs, and audits related to software are effectively … addressed and documented. Skills & Experience: Demonstrable experience in QA/RA for software in medical devices or a related field Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software Experience with software validation, V&V testing, and risk management (ISO 14971) Familiarity with software configuration management, cybersecurity standards More ❯

Manufacturers. Your Responsibilities Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit processes Be involved in maintaining … equivalent Work experience - Minimum of four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc. … demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable Skills Work experience - Experience working with ISO 27001 Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information Ferociously curious - You like going down rabbit holes, understanding More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity to join a fast-growing MedTech company at the forefront of More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity to join a fast-growing MedTech company at the forefront of More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity to join a fast-growing MedTech company at the forefront of More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity to join a fast-growing MedTech company at the forefront of More ❯