Regulatory Specialist

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The company are a well known medical device company, currently undergoing an expansion. The company specialise in the manufacture of 3D stents, and have just been acquired by an international pharmaceutical company. Your role as a Regulatory Affairs Consultant will be to be responsible for the management of the company's regulator affairs activities. Responsibilities:Management of regulatory submissions to regulatory authorities for the company's products.Management of routine regulatory activities.Maintenance of existing global regulatory approvals.Maintenance of existing CE mark, PMA files and post market surveillance activities. Support the preparation of clinical study reports from IDE, OUS amd Post Approval clinical studies.Provide input to regulatory interface to the company's clinical amd commercial operations. Requirements:BSc in Science, Engineering or relative disciplines.8 yeears' experience in regulatory affairs within the medical device industry.Excellent oral and written communication skills.Understanding of regulatory strategy and determination of documentation requirements, timelines, and budgets.Proficient in all Microsoft Office Applications. This is an excellent opportunity to work as part of a global medical device company, as part of an enthusiastic Regulatory team, alongside innovative Regulatory Specialists. 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