Job Title

Graph Database Architect Experience :15 -20 years Location : Remote Primary SkillsGraph Database ArchitectureKnowledge Graph EngineeringLife Sciences & Medical Device Domain ExpertiseRegulatory Compliance (FDA ISO GxP MDR/IVDR)Job DescriptionWe are seeking a highly experienced Graph Database Architect / Lead Knowledge Graph Engineer with 15+ years of experience in data architecture and advanced analytics, with deep expertise in graph databases and life sciences & medical device regulatory domains.The role focuses on designing and delivering enterprise-grade graph and knowledge graph solutions to support regulatory intelligence, clinical data integration, product traceability, quality management, and compliance analytics in highly regulated environments.Key ResponsibilitiesGraph & Knowledge Graph ArchitectureDefine and lead the enterprise graph database and knowledge graph strategy.Design and implement scalable graph models to represent:Product, component, and device hierarchiesRegulatory submissions and requirementsClinical, quality, and post-market data relationshipsData lineage, impact analysis, and traceabilitySelect and architect solutions using graph technologies such as:Neo4j, Amazon Neptune, Tiger Graph, Janus Graph, or equivalent Ensure high performance, scalability, availability, and security of graph platforms.Life Sciences & Medical Device Domain ExpertiseBuild graph solutions supporting core regulated business processes:Regulatory submissions and change impact analysisClinical trials and evidence managementQuality systems (QMS, CAPA, complaints, audits)Manufacturing traceability and device history recordsPost-market surveillance and vigilance reportingModel and maintain relationships across structured and unstructured datasets relevant to life sciences and medical devices.Ensure solutions comply with global regulations and standards, including:FDA 21 CFR Part 11 ISO 13485 GxP (GMP, GCP, GLP) MDR / IVDR (EU) HIPAA, GDPR, and data privacy requirements