6 of 6 Remote/Hybrid ISO 13485 Jobs in England

scale effectively. You will take full ownership of the Quality Management System (QMS), oversee medical device compliance, and act as the internal lead for ISO standards. This role combines strategic oversight with hands-on execution and will be critical in building scalable, audit-ready processes. There is also … product develops (features, integrations, deployments) Work closely with product and engineering teams to embed compliance into development processes Act as the internal lead for ISO standards (including ISO 13485 and ISO 27001) Maintain audit readiness across documentation, policies, and controls Lead preparation for audits, inspections ...

scale effectively. You will take full ownership of the Quality Management System (QMS), oversee medical device compliance, and act as the internal lead for ISO standards. This role combines strategic oversight with hands-on execution and will be critical in building scalable, audit-ready processes. There is also … product develops (features, integrations, deployments) Work closely with product and engineering teams to embed compliance into development processes Act as the internal lead for ISO standards (including ISO 13485 and ISO 27001) Maintain audit readiness across documentation, policies, and controls Lead preparation for audits, inspections ...

personable manner. Highly motivated and driven to improve and develop processes. Desirable Commercial or Academic experience in the neuroscience domain. Knowledge of GCP, ISO13485, ISO27001 and/or other similar quality systems. Understanding of Design Patterns. Understanding of Agile concepts. Knowledge of Git and DevOps. Knowledge of Docker and Kubernetes. ...

execute verification and validation strategies (including qualified tools and fixtures); and lead design transfer activities. Regulatory Compliance and QMS: Ensure supplier activities operate under ISO 13485 - compliant processes and deliver complete DHF/Technical Documentation regulatory expectations; align development to applicable standards. Risk, Submission and Audit Support: Lead … document risk management (ISO 14971), ensure readiness for UDI, labelling, post market surveillance, and change control, and support regulatory submissions and notified body audits by presenting clear technical rationales and objective evidence. Cross Functional and Stakeholder Integration: Integrate the electronics/software workstream with assay/chemistry, mechanical design ...

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 ...

embed a culture of quality across the business. QA Specialist key responsibilities: Own and maintain the document management system, ensuring all quality documents meet ISO 9001:2015 requirements. Design and deliver staff training on QMS processes, keeping training records accurate and up to date. Administer the Non-conformance … working closely with the H&S competent person and relevant duty owners. QA Specialist requirements: Hands-on experience working within a Quality Management System (ISO 9001:2015 and 13485:2016), ideally in the Life Sciences or Medical Devices sector. Practical involvement in internal and external audits. Confident with ...