8 of 8 ISO 13485 Jobs in the South East

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 ❯

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 ❯

data. Medical Device Compliance : Ensure software meets regulatory requirements for medical devices (e.g., IEC 62304). Collaborate with quality assurance teams to document software development processes in compliance with ISO 13485. System Integration : Work with multidisciplinary teams to integrate software with Raman hardware and peripherals. Ensure smooth communication between different hardware components and data systems. Integrate cameras, microscope motion … . Soft Skills : Strong problem-solving skills and attention to detail. Ability to work in a multidisciplinary team and adapt to dynamic requirements. Regulatory Knowledge : Understanding of IEC 62304, ISO 13485, or other medical device software standards is desirable, but not necessary. More ❯

data. Medical Device Compliance : Ensure software meets regulatory requirements for medical devices (e.g., IEC 62304). Collaborate with quality assurance teams to document software development processes in compliance with ISO 13485. System Integration : Work with multidisciplinary teams to integrate software with Raman hardware and peripherals. Ensure smooth communication between different hardware components and data systems. Integrate cameras, microscope motion … . Soft Skills : Strong problem-solving skills and attention to detail. Ability to work in a multidisciplinary team and adapt to dynamic requirements. Regulatory Knowledge : Understanding of IEC 62304, ISO 13485, or other medical device software standards is desirable, but not necessary. More ❯

in Oracle Cloud (OCI) or other cloud platforms (AWS, GCP) Experience with Jira, Confluence, or similar project management tools Knowledge of compliance frameworks and standards (e.g. GDPR, HIPAA, ISO27001, ISO13485) Key Attributes: Collaborative mindset Willingness to learn, cross-train, and upskill in new technology Hands-on approach to exploring new technologies and developing proofs of concept (POCs) Strong problem-solving 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 ❯

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 ❯