that to be considered for this role you must have the right to work in this location. Responsibilities: Oversee and manage a quality management system (QMS) that complies with ISO13485 standards. Handle document control, change management, corrective actions, training records, audits, and supplier oversight. Lead internal and external audits, ensuring systems are always ready for inspection. Develop … marking, MHRA Class I-II, FDA registration, and 510(k) processes. Maintain technical files and coordinate cross-functional inputs to meet regulatory deadlines. Key Skills and Requirements: Experience managing ISO13485-compliant QMS and leading audits. Familiarity with Software as a Medical Device (SaMD) is essential. Strong knowledge of UKCA, MHRA, FDA regulations, and cybersecurity standards such as More ❯
that to be considered for this role you must have the right to work in this location. Responsibilities: Oversee and manage a quality management system (QMS) that complies with ISO13485 standards. Handle document control, change management, corrective actions, training records, audits, and supplier oversight. Lead internal and external audits, ensuring systems are always ready for inspection. Develop … marking, MHRA Class I-II, FDA registration, and 510(k) processes. Maintain technical files and coordinate cross-functional inputs to meet regulatory deadlines. Key Skills and Requirements: Experience managing ISO13485-compliant QMS and leading audits. Familiarity with Software as a Medical Device (SaMD) is essential. Strong knowledge of UKCA, MHRA, FDA regulations, and cybersecurity standards such as More ❯
Croydon, Surrey, England, United Kingdom Hybrid / WFH Options
UNICORN RESOURCING LIMITED
engineering governance activities, including Critical Design Reviews (CDRs). Collaborate with verification and validation teams to support defect triage and resolution. Monitor regulatory standards, ensuring compliance with IEC 60601, ISO 14971, and other relevant frameworks. Conduct risk management activities, including FMEA, hazard analysis, and early-phase risk reviews. Provide technical input, risk assessments, and continuous improvement recommendations during project … s degree (or equivalent) in Biomedical, Mechanical, Electrical, Systems Engineering, or related discipline. Proven problem-solving skills in high-reliability, life-supporting systems (e.g., ventilators). Demonstrated experience applying ISO 14971 risk management to medical device development. Strong knowledge of IEC 60601-1 standards for safety and performance in medical systems. Background in systems engineering disciplines: requirements management, architecture … V&V, and release. Proficiency in requirements engineering and risk analysis techniques across the device lifecycle. Strong understanding of ISO/IEC/IEEE 15288 systems engineering lifecycle within regulated environments. Experience working cross-functionally in multidisciplinary teams. Desirable Skills Experience in R&D within regulated industries, ideally under ISO13485 and IEC 60601. Knowledge of real 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 ❯
London, South East, England, United Kingdom Hybrid / WFH Options
Client Server Ltd
Lakes and Data Warehouses; create robust data transformation processes that ensure data quality, consistency and security and implement automation workflows. You will help to maintain compliance with ISO27001 and ISO13485 requirements for healthcare data management and ensure that security first practices are employed in all data processing solutions to protect sensitive patient information. This is a great opportunity to join … working with sensitive patient data You have a strong understanding of healthcare data standards (HL7, FHIR, OMOP, SNOMED) and data modelling; as well as healthcare technology and regulatory requirements (ISO13485, ISO27001) You have experience of managing data in Azure using tools such as Azure Data Factory, Azure Databricks, Azure Synapse Analytics You have a good knowledge of Data Lake and More ❯
