19 of 19 ISO 13485 Jobs in London

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 ...

surveillance, complaint handling, quality engineering, and risk management within regulated industries. Knowledge of medical device regulations and standards, including EU MDR 2017/745, ISO 13485, ISO 14971, and 21 CFR 820. Excellent communication and stakeholder management skills, with the ability to work effectively across global cross ...

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 ...

tools in daily workflow. Strong understanding of clinical workflows, interoperability patterns, and NHS technical constraints. Experience with regulated healthcare or medical device software (ISO 13485, ISO 14971, IEC 62304). Experience with national NHS APIs such as GP Connect, PDS, PDM, SCR, or BARS referrals. ...

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 ...

automated tests. Nice to have (but we can teach you) Experience in working within a regulated SSDLC process Experience in working in MedTech, including ISO 13485 and ISO 62304 Benefits Competitive salary Share options package - all our employees have ownership in the company Private healthcare 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 ...

Legal & Regulatory Affairs and collaborating with Engineering, you’ll ensure medical software meets global device standards. You will drive design control per IEC 62304, ISO 14971 and ISO 13485, translating complex rules into practical processes for engineers and product teams, and supporting audits and regulatory submissions. #J ...

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 ...

Docker, Kubernetes Experience with medical imaging data e.g. CT or MRI in DICOM format or clinical trial data Experience working in regulated, GxP or ISO 13485 environments Experience in respiratory or interstitial lung disease trials What can you expect from us A comprehensive benefits package that includesan annual ...

other safety-critical systems . Experience within regulated environments or lifesciences would be an advantage. Being Highly proficient with AI. Knowledge of IEC 62304 , ISO 13485 or similar regulated software development standards. Experience with medical alarm systems or other alarm and fault-management systems. Understanding ...

mission-critical or highly regulated software . Desirable Skills & Experience Experience developing medical devices or other safety-critical systems . Knowledge of IEC 62304 , ISO 13485 or similar regulated software development standards. Experience with medical alarm systems or other alarm and fault-management systems. Understanding ...

safety-critical, mission-critical or highly regulated software. Desirable Skills & Experience Experience developing medical devices or other safety-critical systems. Knowledge of IEC 62304, ISO 13485 or similar regulated software development standards. Experience with medical alarm systems or other alarm and fault-management systems. Understanding ...

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 ...

Reset Health are looking for an experienced Scrum Master to serve and guide two agile development teams in our engineering group. Our Live Platforms team is our development ‘fast lane’ making production releases at the ...

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 ...