Medical QA Cyber Security Specialist ISO27001

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My client is a world leading Life Sciences Biotech company who are looking for support within the QA department to work towards securing their product and non-product cyber resiliency and risk mitigation Main responsibilities include:Acts as the point of contact providing regulatory compliance and quality guidance and expertise related to the scope of the SLP policy and process.Extend the Quality Systems Framework with the scope of Medical Device cyber security and cyber resiliency. Monitor regulatory cybersecurity trends and evolving practices that impact the Quality Management Systems.Be responsible for the implementation, oversight and improvement of the SLP policy including dependencies with Production and Process Control, Design Control, Supplier Management, Distribution Control, Risk Management, Computer System Validation, CAPA/Non-Conformance, Quality & Supplier Audits, Packaging & Labelling Control, and others, as appropriate. Must have: -BA in scientific, engineering or life sciences studies- Medical device, biotech or pharmaceutical experience (ISO13485)- ISO9001 QMS standards - Cyber security and risk ISO's/IEC's (62443, 27001)- Technical quality and/or regulatory background within a life sciences field - Must be able to interpret country regulations and guidelines on cybersecurity, and to convert these into practical and pragmatic deliverables. Practical knowledge of regulations (e.g. US FDA cybersecurity guidance) and standards (e.g. ISO 27001)- Extensive knowledge of Quality Systems, including successful interactions with regulatory bodies. Initial 6 month contract£550-£560 a day depending on experience and skillsStart date - March 2021Remote working from UK or NIPlease click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales