Regulatory Affairs Specialist

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Our client is a market leading Medical Device and Pharmaceutical Company. The Regulatory Affairs Specialist is a role in the Microbiology Division's (MBD) Global Regulatory Affairs function. The primary purpose of this role is to assist with accelerating the Business's preparations to meet the requirements of the forthcoming IVD Regulation.The role will encompass assessing existing technical documentation, assisting with defining a strategy to implement timely actions and compilation and inspection of technical information designed to keep our products in compliance with European Regulation. The Regulatory Affairs Associates will report to the Regulatory Affairs Manager.Implement regulatory strategy across a wide portfolio of devices to ensure that company products are safe, legal and meet expectations for compliance with European regulationsAssess, report on and action any gaps in current technical informationWork closely with the Technical teams and Project Management to ensure timely delivery of goalsGenerate records and documentation for inclusion into device-supporting Technical informationCollaborate and assist with the digitization project to enable faster access to legacy informationSkills:Degree or related work experienceRegulatory exposure within the IVD or medical device industryPreferred Skills:Knowledge of IVD DirectiveAbility to plan multiple tasks and effectively prioritize activitiesCapability to drive assignments to completionEffective communicator with management, peers and internal customersExperience of working with active devices (IEC 60601, IEC 61010, IEC 62304) would be an advantagePro-active with proven ability to work under own initiative, and strong team playerCurrent full Driving License (ideally) 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