Role SummaryWe are seeking a highly specialized Medical Device Consultant to take a leading role in product development, global regulatory compliance, quality systems, and risk management. The consultant will operate as an integral part of cross-functional client projects, providing critical expertise that directly supports patient safety, regulatory compliance, and market success of high-risk Class III cardiovascular devices. This role is vital to ensuring our clients’ innovations meet stringent global requirements.Key ResponsibilitiesLead product development activities from concept through commercialization for high-risk cardiovascular devices.Drive EU MDR submissions and prepare Technical Documentation in compliance with Annex II & III.Lead and manage CAPAs, including root cause analysis, tracking, and board-level reporting.Execute regulatory strategies for FDA, MDSAP, CDSCO (India), and TFDA (Taiwan).Conduct internal audits and ensure compliance with ISO, ISO, and MDSAP.Lead obsolescence management initiatives across electronic and mechanical components.Coordinate cross-functional, cross-site teams across Asia, Europe, and the US.Oversee specialized testing and validations for implantable devices, including EMC, biocompatibility (ISO), hemodynamic performance, fatigue/durability testing, RoHS, explosion protection, EO/gamma sterilization, packaging integrity, and IQ/OQ/PQ validations per ISOand ISOCollaborate closely with R&D, Regulatory, Quality Assurance, SCM, and Manufacturing to drive compliantinnovation.Lead qualification of injection-molded components and manage SAP-based material master and change control workflowsRequired Expertise15+ years of experience in Medical Device Engineering, R&D, and global project leadership.Proven expertise in EU MDR submissions for Class III and Class II devices, particularly heart failure systems, transcatheter technologies, and surgical heart valves.Must have experience with heart failure mechanical circulatory support systems.Expert in Windchill Change Management and SAP processes for efficient lifecycle and compliancehandling.Extensive experience in international regulatory submissions and interactions with Notified Bodies. Leadership in obsolescence management and CAPA systems for high-precision medical devices, with expert knowledge of CatsWeb and EPIQ Compliance tools.Hands-on experience in managing high-risk device recalls and Field Safety Corrective Actions (FSCAs), including root cause analysis, global regulatory reporting, and CAPA closure.Familiarity with CAD platforms such as Creo or SolidWorks is an added advantage.Deep regulatory experience with FDA (21 CFR 820), EU MDR, MDSAP, and Asian health authorities (CDSCO, TFDA), ensuring global compliance.Proven track record in implementing lean methodologies and Six Sigma projects.Six Sigma Black Belt certification is required.Certified Internal Auditor (ISO) and Certified Risk Manager.Fluency in English and German is required. Written and spoken Tamil would be a major advantage for regulatory communications. jida88ad2ca jit0624a jiy25a