Compliance Engineer
We are looking for an experienced Compliance Engineer to join a exciting medical device organisation and support regulatory compliance across the full product lifecycle. This medical device Compliance Engineer opportunity would suit someone with strong technical documentation experience who enjoys working across Quality, Engineering, NPD and Manufacturing within a highly regulated environment. The Role As Compliance Engineer, you will be responsible for creating, reviewing and maintaining regulatory and technical documentation to ensure products remain compliant and audit-ready. Key Compliance Engineer responsibilities will include: Authoring and maintaining Technical Files, Design Dossiers and regulatory documentation. Supporting EU MDR and UK regulatory compliance activities. Preparing technical reports, declarations and compliance records. Supporting regulatory submissions, registrations and market access activities. Reviewing documentation for accuracy, completeness and regulatory compliance. Managing documentation updates following design, process or regulatory changes. Supporting risk management and design control documentation. Assisting with Notified Body, Competent Authority and external audit requirements. Monitoring changes to regulations, standards and guidance. Supporting post-market compliance and regulatory change assessments. Contributing to continuous improvement of Quality and Regulatory processes. About You The successful ..... full job details .....
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