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Solutions Recruitment
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Hebburn, Tyne and Wear
Regulatory Affairs Officer
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Job Type: Full-time |
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Overview
My client is a leading innovative manufacturer of cutting-edge products for the medical device and healthcare sectors. With a proud history and enviable working environment, my multi-site client seeks a Regulatory Affairs Officer to join their Regulatory Affairs team at their manufacturing site in Tyne & Wear. Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Officer will be tasked with covering and maintaining the RA/QA system in accordance with the latest relevant product industry standards and assist in the registration of devices with worldwide regulatory and legislative bodies. Main responsibilities Comprehensive understanding of regulatory requirements applicable to medical devices Working knowledge of 13485 & 93/42/EEC & MDSAP Ensure technical files are maintained and reviewed regularly against all regulatory standards. In Q Pulse System ensure all codes are allocated to relevant technical files, obsoleting and archiving as appropriate. Ensure relevant languages are present on required documents Ensure Declarations of Conformity up kept up to date and embed into Q Pulse System. Allocate GMDN code nomenclature and name to all products. On MHRA website ensure all information is current and up to date. Liaise with the Quality department on aspects of quality related documentation where required. Work to current MDR and advise MDR updates with regards to changes required. Keep abreast of current regulatory updates and advise where appropriate Work alongside NPD in the process of incorporating new products into the business, ensuring all relevant documentation is available and stored in the correct areas for easy access. Update any relevant databases as assigned. Ensure naming conventions are consistent throughout all documentation. To be considered for the role, it is essential that you possess demonstrable experience gained in the field of regulatory affairs within the medical device, healthcare and/or pharmaceutical industries. Candidates must possess an up to date and comprehensive knowledge of the latest legislations and regulations that govern the sector and a constant commitment to adhering to changing standards. Key selection criteria Educated to a minimum of HNC in a related scientific discipline Knowledge of 13485 and 93/42/EEC Knowledge of drafting a Marketing Authorisation Application Attention to detail and meticulous in approach Excellent communication skills Expertise and high levels of competence in utilising Microsoft applications including Excel This is an excellent opportunity to join an industry leading, cutting-edge manufacturer in their field who can offer an enviable working environment.