Senior Regulatory Affairs Specialist

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The company are a globally recognised medical device company, specialising in the manufacture of minimally invasive devices. Role: Regulatory Affairs SpecialistLocation: LimerickContract: An initial 4 month hourly rate contract Your role as a Regulatory Specialist will be to co ordinate, prepare and maintain regulatory submissions on a global level. Requirements:Preparation of procedures and associated templates to allow the generation of MDR Technical Documentation to be submitted to Notified Body.Working with the Notified Body to agree sampling plans for technical documentation review.Completion of technical documentation to support MDR Applications to the Notified Body - designation, classification, Technical FilesAssessing the impact of MDR related changes in other global regulatory regions and determining the impact of the changesLiaising with Regulatory Specialists to ensure that required global submissions are prepared.Working with cross functional team (product management, operations) to ensure a continuity of product supply during planned MDR submission timeline Requirements:Degree in engineering / science disciplines.6+ years experience within the medical device industry, as a Regulatory Affairs SpecialistProven communication skills.Experience working in cross functional teams. No CV ready? Not sure yet? Feel free to contact me for further details. This is an excellent opportunity to work as part of an enthusiastic Regulatory team, within a global medical device companyPlease 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