Regulatory Affairs Specialist

Cure Talent are delighted to be partnered with a growing medical device manufacturer with a broad and diverse product portfolio across areas including IV therapy, diabetes care, surgical, anaesthesia and consumer health. Following continued expansion, they are now looking to add another Regulatory Affairs Specialist to their Quality & Regulatory team.As the new Regulatory Affairs Specialist, you will support the ongoing development, maintenance and execution of regulatory activities across the business. This is a hands-on role with exposure across the full product lifecycle, working closely with internal teams to ensure products remain compliant across multiple global markets while helping to define regulatory strategy.To be successful as the new Regulatory Affairs Specialist, you will have proven experience operating within Regulatory Affairs in the medical device sector, with detailed exposure to technical documentation, global regulatory frameworks including MDR and FDA, and supporting regulatory strategy across a range of products.Key ResponsibilitiesSupport and maintain the Quality Management System in line with ISO 13485 requirementsPrepare, review and maintain technical documentation across MDD, MDR, IVDR, UKCA, FDA and procedure packsEnsure ongoing compliance with applicable regulatory requirements and standardsSupport document control activities including procedures, labelling and product documentationContribute to UDI implementation and product lifecycle activitiesCoordinate and support internal and external auditsMonitor regulatory changes and support implementation across the businessExperience and Skills RequiredProven Regulatory Affairs experience within the medical device industryExperience supporting regulatory strategy and submissions activitiesWorking knowledge of MDR and FDA regulatory frameworksStrong understanding of ISO 13485Experience working with technical documentation and regulatory filesStrong organisational skills with attention to detailAbility to work cross-functionally within a regulated environmentIf you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply nowTPBN1_UKTJ