51 to 53 of 53 ISO 13485 Jobs in England

Senior role within a manufacturing or commercial environment across multiple sites. Experience of compliance regulations and how it relates to IT, such as ISO13485 and ISO9001 Experience of ISO27001 an advantage. Proven experience of managing a team. Experience of training users in new application use. Excellent skills in leadership, communication ...

assurance activities within our Healthcare division. You will work closely with the Validation Manager to ensure systems (including SAP) and quality processes meet GDP, ISO, FDA, and EU Annex 11 standards. Your Tasks Lead and support Computer System Validation (CSV) activities, including planning, executing, and documenting validation, re-validation … other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU Annex 11. Experience in healthcare, pharmaceutical, or medical device environments. Confident in audits, inspections ...

experience in supervising teams and delivering complex projects. Strong knowledge of software medical devices or safety-critical systems. Familiarity with ISO standards (ISO9001, ISO13485) and Systems Engineering V-Model. Skilled in systems thinking, engineering, or integration within MedTech or similar sectors. Qualifications Degree (or higher) in a Scientific/ ...