Medical Device Company in the North East are seeking a Regulatory Specialist on a 6 - 12 Month Contract to start ASAP You would be responsible for implementing an efficient program to ensure that all Europe, Middle East and African (EMEA) registrations, including Technical Files and country specific registration of the products are achieved to an agreed schedule. Role develop and implement strategies that will ensure the timely introduction of products onto the international market Prepare complete and scientifically sound regulatory submissions . Interact and work with country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure a timely approval process. . Implement the creation and development of Technical files for both the IVD and Medical Devices Directives. . Review all baseline (new product) labelling, marketing and training materials for regulatory compliance within EMEA Responsible for maintaining the effectiveness of the Quality System at the site in accordance with the companies requirements and applicable regulations. Maintain awareness and ensure compliance with site EHS policy and procedures. If interested please call Tasmin Choudhury on 0207 758 7322
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