Role Summary

We 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 Responsibilities

• Lead 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 13485, ISO 14971, 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 10993), hemodynamic performance, fatigue/durability testing, RoHS, explosion protection, EO/gamma sterilization, packaging integrity, and IQ/OQ/PQ validations per ISO 13485 and ISO 14708.
• Collaborate closely with R&D, Regulatory, Quality Assurance, SCM, and Manufacturing to drive compliant innovation.
• Lead qualification of injection-molded components and manage SAP-based material master and change control workflows.

Required Expertise

• 15+ 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 compliance handling.
• 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 13485) and Certified Risk Manager.
• Fluency in English and German is required. Written and spoken Tamil would be a major advantage for regulatory communications.