Regulatory Affairs Specialist - Permanent Are you an experience regulatory specialist from the medical device sector? Would you like to work for an established and fast growing company, at the forefront of diagnostic technology? This Stirling based company could be ideal for you! Key Roles and Responsibilities* Creation and management of technical files of all legal manufactured products* Creation of QA/RA plans for the design and development teams to support Global markets up to the formation of the standard dossier.* Creation and maintenance of harmonized standards compliance plans* QMS updates required for higher risk IVD's such as PMA and WHO pre-qualification programme activities.* Review and approval of change requests for regulatory impact assessment* Creation of process for the management of approval of global marketing collaterals and localization process* Review and approval of marketing collaterals Essential skills* Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EEC/IVDR* Development and writing of CE marking technical files* Knowledge of Adverse event reporting in clinical environment* Detailed knowledge of post market regulatory activities including FSCA, incident reporting* Experience and knowledge of vertical and horizontal standards for IVD medical device instruments and assays in the point of care.* Experience of working in an IVD or medical device design and manufacturing environmentApply today!
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