Regulatory Affairs Specialist (x2)

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The company are a globally recognised medical device company, specialising in the manufacture of a broad range of products including catheters and stents. Role: Regulatory Affairs SpecialistLocation: GalwayContract: An initial 6 month Your role as a Regulatory Specialist will be to ensure regulatory compliance for assigned product lines. Responsibilities: Determines regulatory pathways for various projects including product classification and subsequent regulatory submission to Regulatory agency/Distributor as required.Construction of Technical Files and associated documentation and/ or regulatory rationales.Analyses and makes recommendations regarding field complaints.Participates in and assists with facility inspections, Notified Body Audits, TGA and other inspections/ audits as required.Interact with various levels of management, external agencies and companies.Performs other related duties and tasks, as required. Requirements:Bachelor's Degree in Engineering / Science disciplines5+ years experience as a Regulatory Specialist within the medical device industryDemonstrated knowledge of the Medical Devices DirectiveDemonstrated and verifiable experience with authoring regulatory submissionsExcellent communication skillsStrong interpersonal skills This is an excellent opportunity to work with an enthusiastic Regulatory team, within a globally recognised medical device company. No CV ready? Not sure yet? Feel free to contact me for further details. 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