76 to 100 of 146 ISO 13485 Jobs in the UK

to detail and commitment to quality excellence Preferred Skills Experience with automated testing frameworks and tools Knowledge of GxP, 21 CFR Part 11, or ISO 13485 standards Background in clinical data validation or laboratory testing environments Familiarity with electronic health record (EHR) systems Experience with Agile development methodologies More ❯

integrating automated liquid handling solutions Participation in product development and experience with verification and validation activities for automation workflows; familiarity with regulated environments (e.g., ISO 13485, IVD, CLIA) is helpful but not required. Strong collaboration and communication skills, with the ability to work in fast-paced, cross-functional More ❯

problem-solving skills and attention to detail Preferred Siemens Polarion certification(s) Experience in regulated industries (Medical Device, Automotive, Aerospace) Knowledge of compliance standards (ISO 13485, IEC 62304, FDA CFR 21 Part 11, ASPICE, etc.) Experience with Polarion's REST API and XML-based configuration Familiarity with CI More ❯

expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … 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 More ❯

expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … 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 More ❯

expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … 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 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., ISO 13485, IEC 62304) for medical devices Write clean, efficient, and well-documented code following best practices Participate in code reviews, testing, and continuous More ❯

Expertise in plastics materials and processing (e.g., injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization). Knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. Proficiency in CAD design and PDM software (e.g., Creo, SolidWorks). Understanding of ANSI/AAMI/ISO More ❯

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 More ❯

My client is a leading AS9100 and ISO 13485 accredited UK contract electronics manufacturer with over 30 years' experience based in Luton, Bedfordshire. They work within a range of industry sectors with vastly experienced and qualified staff offering tailored bespoke solutions to all their clients. Why Join? They 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 More ❯

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) Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts to cross-functional More ❯

is an integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create More ❯

in a similar role. Proficient in both 2D and 3D CAD/surface modelling, preferably Solidworks. Experience in packaging design. Working knowledge of MDR, ISO 13485 compliance. Understanding of international regulatory requirements, such as US FDA and Japan FDA. Familiar with electronic document management systems, project management software More ❯

The Role Oversee all aspects of the Validation Program to ensure that validation processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC; IVDR 2017/746 and other appropriate regulations and standards. This includes site safety requirements and applicable GxP and More ❯

part of a multidisciplinary R&D team. Key Responsibilities: Lead PCB design, schematic capture, and system-level integration (Altium/KiCAD) Ensure compliance with ISO 13485 and IEC 60601 for medical device safety Collaborate with software, mechanical, and chemistry teams on integrated solutions Analog/digital circuit design More ❯

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) Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts to cross-functional More ❯

bring to the role: Essential Requirements: Expert knowledge in Medical Device and Combination product regulations (EU MDR, FDA CFR Part 820 and Part 4, ISO 13485) Functional Breadth - Quality Management, Change Control and Audit Management Project Management Skills - Critical Negotiations, Influencing Skills and Collaboration across boundaries Excellent communication More ❯

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) Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts to cross-functional More ❯

collaboration and regulatory documentation Based in the UK with the ability to work in a hybrid model; experience with QMS or regulated environments (e.g. ISO13485) is a plus This is a high-impact role in a mission-driven company where data science directly supports patient outcomes. If you're passionate More ❯

in Python and ML frameworks such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Robert Walters Operations Limited is an employment business and employment agency and welcomes More ❯

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 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 Purchasing to ensure that all Supplier generated products and components are compliant. Ensure compliance with all Documented Quality system, FDA QSR’s and ISO 13485 requirements during day to day and assigned audit/CAPA activities. Maintain a good level of housekeeping in designated areas and observe … experience: Good technical understanding of manufacturing equipment and processes is required. In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. Strong … and problem solving is required. Understanding of the NPI (New Product Introduction) process and Process Validation is preferred. A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Strong mentoring, coaching and leadership skills are required. Demonstrated project management and project leadership abilities. TCS is consistently More ❯

a wider system. Collaborate with external electronics and software partners, ensuring mechanical designs accommodate technical interfaces. Maintain technical files and documentation in line with ISO 13485 and MDR requirements. Provide mentorship to junior engineers, reviewing designs and supporting development. About You Experienced mechanical engineer (7+ years), ideally with More ❯