Regulatory Affairs Specialist

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I'm currently working with medical device company based in Clare who are looking for a regulatory affairs specialist to join their team.You will be joining a company that are committed to advancing health care for every person.You will be joining a great team and will be provided with great training and support.This is a permanent role with great benefits.What will I be doing as a Regulatory Affairs Specialist?Preparation and maintenance of CE technical files in compliance with current IVDD and preparation for compliance to new IVDR.Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.Management of Field Action process for AU products.Review and approval of device modification proposals.Review and approval of all product labelling.Control of distribution of product from regulatory perspective through regulatory stop ship programParticipation in Internal and External Quality Audit as required.Participation in Management Reviews of the Quality & Environment System as required.Communication to management on Regulatory affairs issues, which require addressing.Support, where required, in Global RA tasks / projects, which may include supporting RA colleagues outside of the company.What I need to be a Regulatory Affairs Specialist?

Will be qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field.Have a minimum of 1 years' experience in a QA or RA role within a manufacturing facility.Excellent written and communication skills are essential.Knowledge and understanding of the IVDD Directive and the associated harmonised standards.Knowledge and understanding of ISO13485 and the FDA QSRs.Experience of product registrations is desirable.If you think the position in Clare is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. If you think you might be interested in becoming a Regulatory Affairs Specialist and looking for more information, I will contact you upon application and discuss this further with you! 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