8 of 8 ISO 13485 Jobs in the East of England

precision, integrity, and a forward-thinking approach. You will act as the go-to subject-matter expert for all aspects of software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and AI-specific guidance such as ISO … notified bodies. Design and execute Qureight’s digital biomarker validation strategy in the US and EU markets. Provide expert guidance on software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, ensuring all systems ...

notified bodies. Design and execute Qureight's digital biomarker validation strategy in the US and EU markets. Provide expert guidance on software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, ensuring all systems … relevant systems. Embed a culture of quality awareness through training, workshops, and mentoring, ensuring all staff are competent and compliant with GCP, ISO standards, and internal policies. Support the Quality Manager in maintaining the Business Management System (BMS) as it relates to GCP and clinical operations. Develop and track ...

systems Lead firmware architecture, requirements definition, and design from early concept through product release Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971.Act as the firmware compliance leader, guiding the team … experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages Demonstrated experience working within an ISO 13485certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied to software ...

Defining and improving firmware lifecycle processes, documentation, and audit readiness Working closely with Quality, Regulatory, and Systems Engineering teams Ensuring compliance with IEC 62304, ISO 13485, and medical device development standards Contributing to architecture, design reviews, risk management, and verification activities Mentoring engineers and supporting best‑practice adoption … regulated or safety‑critical domains (medical devices preferred but not essential) Strong understanding of structured development processes and documentation Familiarity with IEC 62304, ISO 13485, or similar compliance frameworks Ability to collaborate effectively with Quality & Regulatory teams A proactive mindset and confidence in leading technical direction Why Join ...

Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc) Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least ...

improve engineering processes and elevate team capability. Product Development Experience delivering hardware‐based products through a structured development lifecycle in a quality‐driven environment (ISO 9001, ISO 13485, or similar). Comfortable with verification, design reviews, configuration control, interface management, and risk assessment. Experience collaborating with manufacturing ...

HPLC, spectroscopy, ELISA, protein characterization, or related instrumental methods; experience with additional techniques is a plus. Working knowledge of cGMP and/or ISO 13485 requirements, including CAPA, risk assessments, deviation investigations, and change control. Experience with statistical data analysis tools such as Minitab, JMP, or equivalent software. ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...