Save Job Back to Search Job Description Summary Similar JobsMust have Medical Device Regulatory ExperienceLondon BasedAbout Our ClientMy client is an established medical device business with a small team based in London. They currently have a device approval in Europe and is currently expanding to other regions including USA. Looking for a Regulatory Affairs Manager - RA/QA to join the high performing team.Job DescriptionRegulatory Affairs Manager - RA/QAMain duties include :QMS managementResponsible for management and planning of the internal audit programme and conducting internal auditsPost-Market Surveillance activitiesMDR, FDA planning and implementation and regulatory support for other regionsReview of technical files, Risk Management and GSPRThe Successful Applicant- University degree in relevant life science, scientific or engineering-based discipline- A minimum of 4 years working in an MDD/MDR /FDA Regulatory/ISO13485 environment- Good understanding of EU MDD/MDR,FDA, ISO 13485 requirements and ability to communicate and provide training on these technical and regulatory documents- Any experience of FDA submissions would be highly beneficialWhat's on OfferCompetitive Basic , Health care , BonusContactChloe BaverstockQuote job refJN-022025-6667926Phone number+44 1727 730 144Job summaryJob functionLife SciencesSubsectorRegulatory AffairsSectorHealthcare / PharmaceuticalLocationSouth West LondonContract typePermanentConsultant nameChloe BaverstockConsultant phone+44 1727 730 144Job referenceJN-022025-6667926
