to control other medical devices. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the 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 ISO13485 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 »
Support function. A knowledge of clinical settings e.g. hospitals would be highly advantageous. Experience with, or an understanding of key medical device regulations e.g. ISO13485, IVDR etc. MSc/PhD in an engineering or scientific discipline, e.g. molecular biology, infectious diseases, genomics, biomedical engineering, or a related more »
South West London, London, United Kingdom Hybrid / WFH Options
Austin Vita
reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »
CAD, and manufacturing design in a regulated setting. Comprehensive knowledge of regulatory standards, including FDA and CE marking for Class III devices. Familiarity with ISO13485, ISO 14708, and other relevant medical device standards. What Sets This Role Apart: Collaborate with top minds in an innovative, ethical more »
processes including injection moulding, machining and fabrication Depth of knowledge of manufacturing processes (for plastic/metal) and its design requirements Strong knowledge of ISO13485 or other quality management systems Ideal but not compulsory: Medical device development experience Project management experience Understanding of electrical engineering integration Consultancy experience Please attach more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
into the pharmaceutical market About Us: We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO13485, European regulations, FDA regulations, and other global standards for medical devices. Join our team and be part of a growing consultancy where more »
