Save Job Back to Search Job Description Summary Similar JobsContribute to a therapy area that changes livesJoin an excellent team of leadersAbout Our ClientOur client is a medical device developer and manufacturer, supplying clinics worldwideJob DescriptionRepresent role model or servant leader model leadership as a member of senior site management team.Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements.Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery.Oversee global product registrations and submissions, including CE marking and international approvals for UK productsSupport in defining regulatory pathways early in product development, including Intended Use and Risk Classification.Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.Maintain and enhance the Quality Management System (QMS).Lead internal and supplier audits, investigations, and corrective actions.Analyse QA data to drive continuous improvement and risk mitigation.The Successful Applicant- Extensive experience in a 13485 setting - Extensive knowledge of MDR and FDA Regulations - Strong leadership track recordWhat's on Offer- Package TBCContactJames HarrisQuote job refJN-082025-6813867Phone number+44 172 773 0106Job summaryJob functionEngineering & ManufacturingSubsectorQuality, TechnicalSectorIndustrial / ManufacturingLocationSunbury-On-ThamesContract typePermanentConsultant nameJames HarrisConsultant phone+44 172 773 0106Job referenceJN-082025-6813867
