15 of 15 Remote ISO 13485 Jobs

and strategically minded RA/QA Senior Specialist with deep expertise in Software as a Medical Device (SaMD) and artificial intelligence (AI) regulatory frameworks, including the EU AI Act, ISO/IEC DIS 42001 (AI Management System), ISO/IEC 23894 (AI Risk Management), BS 30440:2023 (Validation framework for AI in healthcare), and MHRA guidance on Software … environment, ensuring alignment with evolving global standards and supporting innovation in regulated software development. Provide strategic oversight for interpreting and implementing regulatory frameworks such as the EU AI Act, ISO/IEC DIS 42001, ISO/IEC 23894, BS 30440:2023, ensuring comprehensive alignment with ethical, technical, and compliance considerations specific to AI and LLM applications in SaMD. … translating complex regulations into clear, strategic actions for cross-functional teams. Software Development Lifecycle: Provide strategic leadership over the software development and release management process, ensuring comprehensive compliance with ISO 62304 and ISO 13485. Collaborate closely with engineering leadership to ensure that software modifications and updates adhere rigorously to regulatory and quality expectations before approval and deployment. Lead More ❯

and Line Balance Responsible for working with Quality including management of NCMR's and CAPA's, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products. Contribute to the successful execution of departmental and company goals. Regularly update and recommend … and Line Balance Responsible for working with Quality including management of NCMR's and CAPA's, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products. Contribute to the successful execution of departmental and company goals. Regularly update and recommend … with a minimum of 7 years' experience with at least 3 years in a technical leadership role in a biotechnology, pharmaceutical or medical device industry. Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodology A proven track record in manufacturing and process development in a regulated environment. Medical 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 for an experienced embedded systems engineer join a fast-growing MedTech 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 for an experienced embedded systems engineer join a fast-growing MedTech More ❯

from concept to release Collaborate with cross-functional teams including R&D, Quality, and Regulatory Affairs Ensure software solutions are compliant with relevant medical device standards (e.g., IEC 62304, ISO 13485) Contribute to verification & validation testing, documentation, and risk analysis Participate in code reviews, technical design reviews, and software process improvements Required Experience & Qualifications: Bachelor's or Master 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 ❯

Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO 13485) is a plus. Desirable Experience in optical systems, ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯

SQL Experience working with data lakes, warehouses, and large-scale datasets Understanding of data privacy and security principles Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts More ❯

SQL Experience working with data lakes, warehouses, and large-scale datasets Understanding of data privacy and security principles Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts More ❯

Requirements: 2 3 years experience in sales or business development within electronics Demonstrable success in driving new business Excellent communication and negotiation skills Familiarity with ISO9001 and/or ISO13485 Full UK driving licence Ability to travel to East Kent 3 times per week Looking for a role where you can make a real impact? Apply now. Morgan Jones is More ❯

in Python and ML frameworks 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, motion, respiration). Exposure to More ❯

Engineering, Computer Vision, or related field (or MSc + significant experience) Solid grasp of image segmentation, 3D data handling, and deep learning architectures Bonus: experience in regulated environments (e.g. ISO 13485, FDA) ✅ What’s On Offer High-impact work shaping the future of AI in healthcare Collaborate with exceptional talent in a mission-driven environment Flexible remote/ More ❯

and associated documentation Contributing to a shift left culture, improving product definition and test criteria Measuring and reporting on quality KPIs Working with Compliance to support quality certifications including ISO-13485, FDA and more Required skills/experience 10+ years’ experience working within digital product QA Demonstrable understanding of QA best practices Experience leading manual and automation test initiatives More ❯

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 ❯

standards. It requires attention to detail, an analytical and structured approach, and a great ability to work with people across the business. You'd be responsible for: Knowing the ISO standards applicable to us (13485, 14971, 62304, 82304 in particular) and understanding how they map onto day-to-day Flok activities and tools. Helping us design, implement, and More ❯