20 of 20 Remote ISO 13485 Jobs

supporting their commitment to quality, compliance, and continuous improvement, helping to safeguard the integrity of their products and processes. Drawing on your expertise in ISO 17025 and wider regulatory frameworks, you will take ownership of their Business System Manuals and Technical Documentation, ensuring they remain robust, up to date … and audit ready. As the Management Representative for ISO 13485:2016, you will lead internal audits, monitor regulatory changes, and drive compliance initiatives across the business, working closely with teams to embed quality and regulatory best practices into everything they do. Whether maintaining technical documentation, leading management reviews … of all in-vitro diagnostic medical devices manufactured and sold by our client and manage all technical documentation. To act as management representative for ISO 13485:2016. Requirements for this role: Demonstrable experience of ISO 17025 accreditation within a laboratory environment. Experience of ISO 9001, ISO More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better 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, ISO 13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional development activities More ❯

points, and collaborate with R&D, engineering, and security teams for issue resolution. • Document testing methodologies, defects, and performance metrics in compliance with FDA, ISO 13485, IEC 62304, and HIPAA regulations. • Support root cause analysis (RCA) and corrective/preventive actions (CAPA) based on test findings. Collaboration & Continuous … tools (e.g., TestRail, JIRA, Selenium, Appium, Cypress). • Familiarity with network protocols, security testing, and performance benchmarking. • Understanding of FDA 21 CFR Part 820, ISO 14971 (Risk Management), and IEC 60601 standards. Preferred: • Experience with cloud-based medical device testing (AWS, Azure, IoT platforms). • Knowledge of cybersecurity frameworks More ❯

or support within a regulated laboratory environment. Strong lab experience is required Strong understanding of laboratory workflows, data management and compliance requirements (e.g. GLP, ISO 13485 quality systems) Hands on experience with LIMS configuration and integration with laboratory instruments and enterprise systems. Ability to analyse complex lab processes More ❯

or support within a regulated laboratory environment. Strong lab experience is required Strong understanding of laboratory workflows, data management and compliance requirements (e.g. GLP, ISO 13485 quality systems) Hands on experience with LIMS configuration and integration with laboratory instruments and enterprise systems. Ability to analyse complex lab processes 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., ISO 13485, FDA guidelines) is highly preferred. 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., ISO 13485, FDA guidelines) is highly preferred. More ❯

demonstrable experience in test automation (preferably Python and Kotlin) • Experience with virtualization, Linux, and remote device management. • Knowledge of medical device regulations and standards (ISO 13485, IEC 62304, 21 CFR 820) Nice to Haves • BS/MS in Computer, Electrical, Electronics Engineering or equivalent industry experience • Advanced certification More ❯

demonstrable experience in test automation (preferably Python and Kotlin) • Experience with virtualization, Linux, and remote device management. • Knowledge of medical device regulations and standards (ISO 13485, IEC 62304, 21 CFR 820) Nice to Haves • BS/MS in Computer, Electrical, Electronics Engineering or equivalent industry experience • Advanced certification 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 ❯

and delivery in public sector context. You have experience in working under quality management and medical device regulations, and are familiar with standards including ISO 13485, 14971, and 62366 (highly preferable). Qualifications While qualifications are valuable, we place equal importance on your hands-on experience as a 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 ❯

with TensorFlow Lite Micro for neural networks. We have some work in quality controlled industries, like medical and intrinsic safety (SIL/IEC61508/ISO13485). Not all work is in those industries, however. Many clients value a working prototype over a polished product. Still, there is a requirement for … know embedded C programming and any one of the following: Embedded Linux e.g. Yocto or Buildroot Python Android build system Networking and communication protocols ISO13485/IEC61508 experience The ideal candidate will also have some familiarity with: Embedded OS use Low power optimisation Rudimentary assembly language Makefiles Basic soldering Unit More ❯

with TensorFlow Lite Micro for neural networks. We have some work in quality controlled industries, like medical and intrinsic safety (SIL/IEC61508/ISO13485). Not all work is in those industries, however. Many clients value a working prototype over a polished product. Still, there is a requirement for … know embedded C programming and any one of the following: Embedded Linux e.g. Yocto or Buildroot Python Android build system Networking and communication protocols ISO13485/IEC61508 experience The ideal candidate will also have some familiarity with: Embedded OS use Low power optimisation Rudimentary assembly language Makefiles Basic soldering Unit More ❯

by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for Dot Compliance is a leading provider of cloud Quality and Compliance management solutions More ❯