11 of 11 Remote ISO 13485 Jobs in England

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 ❯

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 ❯

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 ❯

Electronic Medical Records (EMR)solution called Clinicalvision, designed specifically for the renal market and the management of clinical records for CKD, ESRD and transplant patients. Clinical Computing is an ISO 13485 Medical Device certified organisation. Clinical Computing along with Mediqal H.I., its sister company in the UK, are both members of the Constellation Kidney Group. Key Responsibilities Create … also be familiar with help desk software. Ultimately, you will help maintain our reputation as a company that offers excellent customer support. Responsibilities Undertake activities in accordance with our ISO 13485 Medical Device Quality Management System. Diagnose and troubleshoot technical issues. Ask customers targeted questions to quickly understand the root of the problem. Track computer system issues through 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 ❯

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 ❯

to work in the UK Genedrive is a pioneering medical device company headquartered in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC 62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a … Degree-qualified in a science or engineering discipline Minimum 3 years of experience in a QA/RA role within the IVD or medical device sector Solid understanding of ISO 13485 and ISO 14971 Experience with internal/external audits and training delivery Excellent analytical, organisational, and communication skills Comfortable working independently and within cross-functional teams … Desirable: Knowledge of IEC 62304, ISO 60601, and global radio regulations Experience with global medical device regulations particularly UK, EU and USA Familiarity with the commercialisation of IVD products ISO 13485:2016 Lead Auditor training This role is a unique chance to step into a high-impact position within a fast-moving and rewarding sector, apply now 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 ❯

trend analysis, clinical evaluation reports including literature search, post market clinical follow-up studies, and vigilance reporting. Regulatory & Medical Device Compliance Support compliance with UK MDR, EU MDR, and ISO standards (e.g., ISO 13485). Contribute to the preparation of regulatory submissions and audits by providing clinical evidence and safety documentation. Participate in internal and external audits More ❯