to create a culture of inclusion where everyone can thrive at work and beyond. Responsibilities Ensure compliance with regulations governing Software Medical Devices including ISO13485, ISO 27001, and ISO 62304, as well as support for the Quality Management System (QMS) Author technical documentation, and designs … for the United States and Medical Device Software for the European Union. Experience testing and validating software systems. Regulatory Affairs Certification (RAC) Devices, lead ISO13485 auditor, or equivalent. Experience working with legal/regulatory teams to translate regulatory and standard requirements to actionable engineering plans. Experience with consumer-focused software More ❯
days a week) Salary: Dependant on experience + Excellent benefits Responsibilities Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO13485, 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 … effectively addressed and documented. Skills & Experience Demonstrable experience in QA/RA for software in medical devices or a related field Strong knowledge of ISO13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software Experience with software validation, V&V testing, and risk More ❯
days a week) Salary: Dependant on experience + Excellent benefits Responsibilities Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO13485, 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 … effectively addressed and documented. Skills & Experience Demonstrable experience in QA/RA for software in medical devices or a related field Strong knowledge of ISO13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software Experience with software validation, V&V testing, and risk More ❯
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, ISO13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional development activities More ❯
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., ISO13485, FDA guidelines) is highly preferred. More ❯
london, south east england, United Kingdom Hybrid / WFH Options
Oho Group Ltd
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., ISO13485, FDA guidelines) is highly preferred. More ❯
Python applications for medical device software Collaborate with cross-functional teams, including R&D, product management, and QA Ensure software meets regulatory standards (e.g., ISO13485, IEC 62304) for medical devices Write clean, efficient, and well-documented code following best practices Participate in code reviews, testing, and continuous More ❯
such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data (e.g., continuous heart rate More ❯
manual and automated testing, with knowledge of leading QA tools and frameworks. Experience working in regulated environments (e.g., digital health, SaMD) and familiarity with ISO13485, GDPR, and HIPAA. Strong passion for quality and software craftsmanship, with a practical and resourceful mindset. Experience mentoring and collaborating with peers More ❯
manual and automated testing, with knowledge of leading QA tools and frameworks. Experience working in regulated environments (e.g., digital health, SaMD) and familiarity with ISO13485, GDPR, and HIPAA. Strong passion for quality and software craftsmanship, with a practical and resourceful mindset. Experience mentoring and collaborating with peers More ❯
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 More ❯
/or presentations at conferences Experience with data management, for example using Excel, R or SQL Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS More ❯
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 … 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 More ❯
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 … 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 More ❯
Apply security-first development practices in all technical solutions Contribute to team culture through knowledge sharing and mentoring Help maintain compliance with ISO27001 and ISO13485 requirements Participate in technical discussions and architecture planning Required Experience: Strong experience with cloud services and implementing Software as a Service solutions, particularly with Azure … skills and ability to work effectively in a team Enthusiasm for learning and growing as a developer Familiarity with healthcare technology and regulatory requirements (ISO13485, ISO27001) Desired Skills: Experience in building mobile apps Experience working in a healthcare technology company Experience of penetration testing More ❯
Apply security-first development practices in all technical solutions Contribute to team culture through knowledge sharing and mentoring Help maintain compliance with ISO27001 and ISO13485 requirements Participate in technical discussions and architecture planning Required Experience: Strong experience with cloud services and implementing Software as a Service solutions, particularly with Azure … skills and ability to work effectively in a team Enthusiasm for learning and growing as a developer Familiarity with healthcare technology and regulatory requirements (ISO13485, ISO27001) Desired Skills: Experience in building mobile apps Experience working in a healthcare technology company Experience of penetration testing More ❯
