Senior Quality and Regulatory Associate

Job DescriptionOur client is a Global MedTech Company that is a manufacturing leader in Infection Control, Decontamination and Sterilization. With plans for further growth in a highly regulated environment. This role will help to ensure the organisation maintains its impeccable standard of Quality and Regulatory assurance. To achieve this, we have been tasked with identifying and recruiting a Quality and Regulatory Assistant to join their UK team.The ideal candidate will have experience working with Quality Management Systems and will assist the Quality and Regulatory Manager in the implementation of regulatory aspects of the Global QMS to enable a successful MDR/ISO13485 transition to TUV SUD.Key responsibilities will include:Identify areas for improvement. Design, build and implement new quality processes into the organisation. Drive continuous improvement in all aspects of the existing quality operationRisk Management according to ISO14971Post Market Vigilance according to MDR requirementsAssist in the implementation of clinical evaluation and technical file SOPs and review of documents associated with this.Maintenance of Technical DocumentationMaintenance of medical device registrations with MHRA and EUDAMEDKey experience and skills required:QMS experience requiredISO14971/Risk Management experience requiredPMS experience requiredKnowledge / experience of ISO 13485 is desirableIT skillsAble to interact with all levels of the business.Organized and able to prioritize work.
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