2 of 2 ISO 13485 Jobs in Manchester

scaling digital health organisation. Key Responsibilities Quality & Regulatory Leadership Own and maintain the organisation’s Quality Management System (QMS) in line with ISO 13485 Act as the internal lead for the ISO 27001 Information Security Management System (ISMS) Ensure ongoing compliance with HIPAA, DTAC, NHS DSP Toolkit … practical guidance for non-specialist stakeholders Support leadership with compliance reporting and customer or partner due diligence Key Authorities Authority to coordinate and maintain ISO 13485 and ISO 27001 management systems Authority to coordinate evidence and submissions for DTAC, NHS DSP Toolkit, and Cyber Essentials Plus Authority ...

required. Required to learn, understand, and apply relevant legislation, national standards, professional and other guidelines e.g. ISO 9001(2015) Radiotherapy Quality System, ISO13485, Medical Devices Directive 93/42/EEC, Data Protection Act, Caldicott and other relevant standards Requirement for frequent working out of clinical hours to minimize … maintain proper records of all work carried out on the radiotherapy equipment Operate, maintain and develop procedures for the identified system(s) within the ISO 9001-2015 Quality System to ensure system(s) and procedures are fit for clinical use. To prepare reports and to analyse and present complex ...