Quality & Regulatory Specialist

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Our client a medical device company in Oxfordshire are looking for a Quality & Regulatory Associate to join the team. Medical Device Products are certified to CE and ISO standards, and approved by the CSA, FDA, and other agencies. The company are working on notable private and public sector projects to benefit customers and the public.The Quality & Regulatory Associate will support the Manager, Team and Operations in driving manufacturing excellence and cultural change/improvementMake quality decisions on product & quality management systems and to advise on, and assist with hands-on practical operational changes and improvementsMonitor and ensure compliance with international Quality and regulatory standards ISO 13485, FDA, MDD 93/42/EC, MDR and other regulated geographiesEnsure compliance to all processes related to the requirements of Regulatory Affairs & Quality Management SystemsMeasure progress and report monthly against quality objectivesMaintenance of site and country registrations for applicable productsEnsure the promotion of awareness of customer requirements throughout the organisation in adherence with the Quality PolicyProvide documentation for product restrictionsProduce documentation for on-market changesManage through to completion the CAPA processTracking regulatory changes (standards / directives)When required provide support to MDR and vigilance reportingSupport to the Product field corrective actions and product risk management processes.Provide regulatory input to the post market surveillance system to meet regulatory requirements & contribute to sameAssist in external auditsParticipate as an auditor in the internal audit process of the company's quality systemWhere appropriate, provide QA and/or RA requirements and approvals into the design and change control processIf and when required - Assist in the developing and conducting internal and external trainingEnsure compliance with the Company Health and Safety PolicyQualifications:Ideally degree level education or equivalent experience in a hands on roleQuality and/or Regulatory knowledgeMedical Devices or Life Sciences experienceAlthough the list above is detailed applicants from Quality or Regulatory backgrounds are encouraged to apply as development opportunity is on offer if anything is lacking To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales