2 of 2 ISO 13485 Jobs in Oxford

authorities. To ensure that products conform with relevant regulations in territories in which they are sold; OND and ONT operate two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT). Reporting and providing primary support to the Head of QA, the role of the Associate Director … as directed) in any matter. • All activities required to help ensure the QA team achieve their annual objectives and maintain/sustain the ISO9001 & 13485 accreditation. This may require the role to fulfill part of the role of "Person with Responsibility for Regulatory Compliance" as per the EU IVDR. … highly desired. Understanding or experience of computer systems validation is desirable (e.g. GAMP5). Knowledge/Skills/Abilities Essential: Detailed working knowledge of ISO13485, MDSAP requirements and the IVDR are essential. Demonstrable experience of working with external partners and stakeholders, showing a balanced level of discretion and sensitivity to More ❯

the release process. Ensure compliance with regulatory or internal change management policies, including experience with standards surrounding software as a medical device, for example ISO 13485 and ISO 62304. Test Automation Maintain best practices for release management, such as CI/CD (Continuous Integration/Continuous Deployment More ❯