QARA - Software

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Our client is a fast growing compliance consultancy who are looking for a full-time quality or regulatory consultant. There is remote working as part of a decentralised team so could be located anywhere, with occasional travel to client site.As a Quality & Regulatory consultant you will participate in medical device projects contributing to quality assurance and regulatory affairs deliverables for our clients (mainly medical device), enabling them to take cutting edge health technology to market.Key Responsibilities To assist the senior consultants by taking an active role in quality assurance and regulatory client projects (CE, MDSAP and FDA)Reviewing client quality management system and technical documentationProviding gap analysis against applicable EU and global regulatory requirements and standardsTo share the workload of planning, executing and reporting client auditsParticipate in client meetings, and prepare minutes and summaries of discussions regarding complex regulatory issuesSkills requiredKnowledge of software as a medical device (SaMD) or As an internal or supplier auditorDefinition or audit of QMS procedures per ISO 13485Understanding of relevant ISO standards applicable to medical devices, health software, risk management and security (e.g. IEC 60601, ISO 62304, ISO 14155, ISO 14971, ISO 27001)Experience of using issue management and/ or customer relationship management (CRM) systemsAbility and willingness for occasional domestic and international travel To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales