3 of 3 IEC 62304 Jobs in the South West

Prepare and maintain regulatory submissions and documentation including Declarations of Conformity, Technical Files and labelling reviews. Ensure documentation is in compliance with ISO 13485, IEC 62304, ISO 14971, and other applicable standards. Risk Management: Lead and coordinate risk management activities in accordance with ISO 14971, integrating risk assessments … technology. Strong working knowledge of UK MDR, EU MDR, and FDA medical device regulations. Familiarity with technical standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series. Experience with Class I medical devices and SaMD regulatory requirements. Excellent documentation and communication skills – able to More ❯

reasonable commuting distance. What you'll be doing: Develop and optimise SAFERTOS®, including porting to various processor architectures. Ensure compliance with safety standards (e.g., IEC 61508, ISO 26262). Create high-quality design and testing documentation. Collaborate with cross-functional teams to deliver innovative solutions for global clients. What … SAFERTOS). Low-level embedded engineering experience (e.g., Cortex M3/M4, A7). Familiarity with safety-critical standards (e.g., DO-178B/C, IEC 62304). Understanding of networking protocols (TCP, UDP) or embedded software security. Experience with ARM, MIPS, or Power architectures. Exposure to software requirements … SAFERTOS, FreeRTOS, C Programming, Assembly Language, Processor Architectures, Cortex M3/M4/A7, Safety-Critical Software, Software Development Lifecycle, Software Requirements, Configuration Management, IEC 61508, DO 178B/C, ISO 26262, IEC 62304, Networking Protocols (TCP, UDP), Embedded Software Security, Multicore Devices, ARM Architecture, MIPS Architecture More ❯

reasonable commuting distance. What you'll be doing: Develop and optimise SAFERTOS®, including porting to various processor architectures. Ensure compliance with safety standards (e.g., IEC 61508, ISO 26262). Create high-quality design and testing documentation. Collaborate with cross-functional teams to deliver innovative solutions for global clients. What … SAFERTOS). Low-level embedded engineering experience (e.g., Cortex M3/M4, A7). Familiarity with safety-critical standards (e.g., DO-178B/C, IEC 62304). Understanding of networking protocols (TCP, UDP) or embedded software security. Experience with ARM, MIPS, or Power architectures. Exposure to software requirements More ❯