23 of 23 ISO 13485 Jobs in England

outcomes. About the Role We're hiring a QA Compliance Manager to lead a team focused on maintaining and enhancing the Quality Management System (QMS) in compliance with GMP, ISO 9001, ISO 13485, and other regulatory standards. Reporting to the Head of Quality, you'll oversee internal audits, batch record reviews, CAPA systems, and customer audits, while … potential Qualified Person (QP) sponsorship for the right candidate. Key Responsibilities: Lead and develop the QA Compliance team Maintain and improve the QMS in line with EU GMP and ISO standards Oversee internal audits, CAPA management, and batch documentation review Host customer audits and support regulatory inspections Drive continuous improvement and contribute to strategic quality initiatives Support training, change … in a scientific discipline (e.g. Chemistry, Biology, or related field) 10+ years' experience in GMP-regulated environments Strong leadership and people management skills In-depth knowledge of EU cGMP, ISO 9001, and ISO 13485 Experience supporting or conducting batch release under QP supervision Lead Auditor training and a proactive approach to quality improvement Excellent communication, organisation, and More ❯

contribute to the success of a leading medical device company, we want to hear from you! Key Responsibilities: Assist in maintaining compliance with certifications and regulatory approvals such as ISO 27001, ISO 9001, ISO 13485, UKCA, CE, and FDA 510(k). Support the update and maintenance of QMS and ISMS documentation. Help coordinate and conduct … inclusive work environment. The Person Degree or equivalent qualification in Life Sciences, Quality Management, or a related field. 2+ years of relevant experience is preferred. A basic understanding of ISO standards or medical device regulations is desirable. Excellent organisational skills with strong attention to detail. Clear written and verbal communication abilities. A commitment to following procedures and maintaining accurate More ❯

and drive continuous improvement initiatives across the production environment. Job Role Responsibilities: Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with relevant standards (e.g., ISO 9001, ISO 13485, AS9100). Lead internal and external audits, ensuring compliance and preparing for third-party inspections. Analyze quality data and trends to identify areas for … The Candidate: Proven experience in a quality systems or quality assurance role within a manufacturing or production environment - precision environment Strong knowledge of quality standards and regulations such as ISO, GMP, FDA if applicable). Experience with quality tools and methodologies such as CAPA, FMEA, Root Cause Analysis Certification in quality management systems - desirable Excellent communication, analytical, and problem More ❯

Knowledge of design of experiments (DOEs) and design space studies. Knowledge of regulatory requirements and industry standards, such as design controls (21 CFR 820.30), EU MDR 2017/745, ISO 14971, ISO 13485, and GMP. Authoring of global regulatory submissions and supporting agency interactions (e.g. FDA/EMA/notified bodies). Evidence of teamwork, flexibility, and More ❯

to proactively identify and mitigate risks. Work closely with the security team to integrate best practices into new and existing features. Ensure compliance with security standards and regulations (e.g., ISO 27001, SOC 2). Implement monitoring solutions to detect and respond to real-time security incidents. Troubleshoot infrastructure and security issues, performing root cause analysis in production. Mentor junior … cloud platforms (AWS, GCP). Experience with security tools like OWASP ZAP, Burp Suite, etc. Familiarity with Jira, Confluence, or similar tools. Knowledge of compliance frameworks (e.g., GDPR, HIPAA, ISO 27001, ISO 13485). Background in start-up or scale-up environments is a plus. Key Attributes: Strong collaboration skills. Eagerness to learn and upskill in new More ❯

settings and bring clarity to complex technical challenges. This opportunity is ideal for someone with a background in medical device development, particularly within implantable or regulated systems. Familiarity with ISO 14971, ISO 13485, and verification methodologies will be key, alongside strong communication skills and a detail-oriented mindset. If you're looking to make a meaningful impact More ❯

Reviews (CDRs). Collaborate with V&V teams to support defect triage, issue resolution, and validation. Monitor regulatory changes and ensure compliance with standards such as IEC 60601 and ISO 14971. Conduct risk management activities including FMEA and hazard analysis. Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications Essential: Bachelors degree in biomedical, mechanical, electrical, or … systems engineering (or equivalent). Strong background in high-reliability systems (e.g., ventilators). Deep understanding of ISO 14971 and IEC 60601-1 standards. Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release. Familiarity with ISO/IEC/IEEE 15288 lifecycle within regulated product development. Comfortable working in cross-functional teams and dynamic … project environments. Desirable: Experience in ISO 13485-compliant environments. Knowledge of real-time control systems and embedded platforms. Experience in IEC 62304 Strong communication and collaboration skills across engineering, quality, and clinical teams. More ❯

the product from design to manufacturing, solving engineering issues in electronics, firmware, and production instrumentation Maintain, adapt, and optimise existing firmware within the constraints of regulatory compliance (IEC 62304, ISO 13485) Lead electronics design, schematic capture, and PCB layout using Altium Develop LabVIEW applications for test and instrumentation Collaborate with manufacturing partners to troubleshoot and resolve production issues More ❯

product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology 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’ technical support activities. Hands-on More ❯

product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology 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’ technical support activities. Hands-on More ❯

Engineering, Computer Vision, or related field (or MSc + significant experience) Solid grasp of image segmentation, 3D data handling, and deep learning architectures Bonus: experience in regulated environments (e.g. ISO 13485, FDA) ✅ What’s On Offer High-impact work shaping the future of AI in healthcare Collaborate with exceptional talent in a mission-driven environment Flexible remote/ More ❯

Engineering, Computer Vision, or related field (or MSc + significant experience) Solid grasp of image segmentation, 3D data handling, and deep learning architectures Bonus: experience in regulated environments (e.g. ISO 13485, FDA) ✅ What’s On Offer High-impact work shaping the future of AI in healthcare Collaborate with exceptional talent in a mission-driven environment Flexible remote/ More ❯

Engineering, Computer Vision, or related field (or MSc + significant experience) Solid grasp of image segmentation, 3D data handling, and deep learning architectures Bonus: experience in regulated environments (e.g. ISO 13485, FDA) ✅ What’s On Offer High-impact work shaping the future of AI in healthcare Collaborate with exceptional talent in a mission-driven environment Flexible remote/ More ❯

documentation. + Contribute to risk management (FMEA, hazard analysis) and V&V. Key skills: + Strong knowledge of systems engineering lifecycle. + Skilled in risk management and regulatory compliance ISO 1497. + Experience of R&D in a regulated environment, ISO 13485 would be beneficial. The salary will be up to £75k depending on previous experiencewith great More ❯

driver development. Solid understanding of analogue design, low-noise circuitry, and PCB layout. Experience with BLE or Wi-Fi and associated regulatory workflows. Familiarity with medical or regulated environments (ISO 13485, IEC 60601, IEC 62304). This is a unique opportunity to join a forward-thinking company developing next-generation connected healthcare technology. Youll work alongside a passionate More ❯

EKS). An understanding of Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

on the Senior Management Team, influencing company strategy. Embed structured planning, problem solving, and root-cause analysis across the department. Maintain compliance with relevant standards (IEC 62619, UN38.3, UL, ISO 9001/13485). Champion ABT's 4Ts: Transparency, Traceability, Test = Trust. Knowledge, Skills and Behaviours: The successful candidate will demonstrate a combination of the following: Proven leadership More ❯

Comfortable using tools like Jira, TestRail, and writing technical documentation Experience working in cross-functional teams with QA, Product, and Regulatory Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

improvement in patient outcomes. Your new role As QA Compliance Manager, you'll lead a team responsible for maintaining and improving the Quality Management System in line with GMP, ISO, and regulatory standards. Reporting to the Head of Quality, you'll oversee internal audits, batch record reviews, CAPA systems, and customer audits. You'll also contribute to strategic quality … discipline (e.g. Chemistry, Biology, or related field) Extensive experience in GMP-regulated environments (10+ years preferred) Strong leadership and people management skills In-depth knowledge of EU cGMP and ISO standards (9001, 13485) Experience supporting or conducting batch release under QP supervision Lead auditor training and a proactive approach to continuous improvement Excellent communication, organisational, and stakeholder engagement More ❯

supporting clinical trials and ensuring compliance with international standards. Key Responsibilities Define and document system architecture, design inputs, and interfaces. Lead risk management activities (FMEA, FTA) in compliance with ISO 14971. Maintain technical documentation (DHF) for audits and regulatory submissions. Manage system and sub-system requirements with full traceability. Support clinical investigations and verification testing. Collaborate with cross-functional … and regulatory. Drive process improvements and stay current with evolving standards. Skills & Experience Essential: Degree in engineering or a related field. Experience in regulated medical device development. Familiarity with ISO 14971 & ISO 13485. Strong understanding of system-level requirements and V&V principles. Desirable: Experience with implantable or active medical devices. Knowledge of IEC 60601, IEC 62304, or … ISO 14708. Proficiency with document control and requirements management tools. Experience working with clinical and academic partners. Whats on Offer Competitive salary based on experience. Private healthcare, income protection, life assurance. Company pension scheme. 27 days holiday plus bank holidays. Hybrid working. The opportunity to contribute to a transformative medical technology platform. More ❯

Familiarity with SysML, CAD, and simulation software. Experience with analytical methods for FEA/CFD validation. Understanding of MBSE, systems thinking, and PDM. Knowledge of regulated development frameworks like ISO 13485. Excellent communication and data presentation skills. Experience with statistical, experimental, and analytical methods for FEA/CFD validation. Managing CAD data anddocumentation within the PDM. Model-Based Systems … align our BZero sustainability initiative aim to be accredited to SBTI which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485. A full job description can be downloaded on the application Screen . Our core values are Customer Focussed, Respectful, Collaborative, and Agile these More ❯

Familiarity with SysML, CAD, and simulation software. Experience with analytical methods for FEA/CFD validation. Understanding of MBSE, systems thinking, and PDM. Knowledge of regulated development frameworks like ISO 13485. Excellent communication and data presentation skills. Experience with statistical, experimental, and analytical methods for FEA/CFD validation. Managing CAD data anddocumentation within the PDM. Model-Based Systems … align our BZero sustainability initiative aim to be accredited to SBTI which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485. A full job description can be downloaded on the application Screen . Our core values are Customer Focussed, Respectful, Collaborative, and Agile these More ❯

Familiarity with SysML, CAD, and simulation software. Experience with analytical methods for FEA/CFD validation. Understanding of MBSE, systems thinking, and PDM. Knowledge of regulated development frameworks like ISO 13485. Excellent communication and data presentation skills. Experience with statistical, experimental, and analytical methods for FEA/CFD validation. Managing CAD data anddocumentation within the PDM. Model-Based Systems … align our BZero sustainability initiative aim to be accredited to SBTI which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485. A full job description can be downloaded on the application Screen . Our core values are Customer Focussed, Respectful, Collaborative, and Agile these More ❯