15 of 15 Remote/Hybrid ISO 13485 Jobs in England

help ensure that our software design and development activities meet global medical device requirements, leading the practical implementation of IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems) within an agile, iterative environment. You’ll help shape how design inputs, verification, validation … Medical Device Design Control Processes Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with IEC 62304, ISO 14971, and ISO 13485. Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation activities are clearly defined, documented ...

scratch, reporting directly to the technical lead. What you'll be doing: Developing and maintaining Embedded C firmware on STM32 Working within an ISO 13485/IEC 62304 regulated environment Getting to grips with (and improving) a Legacy codebase Helping shape the project scope and timelines from … start What they're looking for: Strong Embedded C on ARM microcontrollers, ideally STM32 Hands-on experience of IEC 62304 and ISO 13485 Keil experience is a bonus Bonus points if you've got opinions on how AI coding tools fit into Embedded work The project is still ...

churned win-back. Complaint handling: Own the customer complaints procedure, built with our Regulatory team to align with our quality management system and ISO 27001. Make sure every complaint is logged, resolved within target and analysed for root causes. Team leadership: Line manage, coach and develop the Customer Success … success platforms and CRM tools, such as Custify, HubSpot or Airtable. Experience of complaints handling within a regulated or quality-managed environment, such as ISO 13485 or ISO 27001. Experience building or scaling a Customer Success function in a growing company. Benefits Competitive Salary Company Pension ...

maintain accurate car stock inventory records. Train customers on equipment use before and after installation. Complete accurate service reports and documentation in line with ISO 13485 and ISO 9001 requirements. Follow health and safety procedures and patient data requirements. Build strong, professional relationships with customers across ...

Take ownership of our medical device regulatory roadmap, working with external specialists and internal teams to progress our Class IIa ambitions, including classification, registration, ISO 13485 readiness, technical documentation and post-market surveillance. Ensure requirements are understood, work is prioritised and progress is driven through to completion. Coordinate … ideally involving Software as a Medical Device (SaMD) and Class IIa requirements. Quality management: Experience implementing, maintaining and improving a Quality Management System, including ISO 9001 and ideally ISO 13485. Data protection and international privacy regulation: Strong working knowledge of UK and EU GDPR, with practical experience managing ...

healthcare partners to deploy continuous clinical-safety assurances across UK healthcare settings. The role prioritises practical risk management, regulatory knowledge (DCB0129/DCB0160, ISO 14971, ISO 13485), and collaboration with vendors and providers to ensure safe #J-18808-Ljbffr ...

Support system integration testing, coordinating test execution across hardware, firmware, and software components and documenting integration test outcomes Contribute to risk management activities under ISO 14971, including review of FMEAs and verification of risk control effectiveness Develop and maintain test infrastructure, fixtures, calibration status and tooling needed to execute … Clear and precise technical writing skills, with experience authoring test protocols and reports that meet regulatory documentation standards Nice to have: Working knowledge of ISO 14971 and ISO 13485 applied to product design and development Experience with hardware‐in‐the‐loop or software‐in‐the‐loop testing ...

technical stakeholders. Desirable Experience supporting software products through regulatory submissions, inspections, audits, or product approvals. Familiarity with standards and regulations such as IEC 62304, ISO 13485, FDA software guidance, EU IVDR, IEC 81001-5-1, or comparable industry frameworks. Familiarity with secure software development practices, vulnerability management, Software ...

fast-paced startup environment. Greatly Beneficial Safety-Critical Design: Experience designing for safety-critical systems or high-reliability applications-especially under standards such as ISO 26262 (automotive), IEC 61508 (industrial), or medical device standards (ISO 13485/IEC 60601/IEC 62304). Mixed-Signal Integration: Practical ...

software for medical devices or another regulated industry, such as aerospace or automotive safety Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304 and IEC 60601, or equivalents A strong understanding of the documentation, traceability and verification required for safety-critical software Experience ...

software for medical devices or another regulated industry, such as aerospace or automotive safety Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304 and IEC 60601, or equivalents A strong understanding of the documentation, traceability and verification required for safety-critical software Experience ...

statistical acceptance criteria and data-driven testing. Biomedical, healthcare or digital-health experience. Experience in regulated medical technology environments. Familiarity with IEC 62304, ISO 13485 or related medical-device standards. We do not require previous experience specifically in hardware or embedded-software testing, web front-end testing, clinical ...

defining the vision. Nice to have: experience in medical devices or another regulated hardware/software environment, with exposure to documentation practices under ISO 13485 or IEC 62304. Nice to have: prior experience setting up or overhauling a ticket intake and triage process from scratch, rather than inheriting ...

other cancers a plus) International experience (work or study abroad) esp in North America, Europe and APAC Experience working within regulated environments (e.g. ISO 13485) What we offer Work that is both challenging and rewarding and has a real positive impact on people's lives Fast growth, ownership ...

role requires a keen user-centric mindset and ability to work with people across the business. You’d be responsible for: Knowing the ISO standards applicable to us (13485, 14971, 62304, 82304 in particular) and understanding how they map onto day-to-day Flok activities and tools Helping ...