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.
Apply online using the form below. Please note that only applications matching the job profile will be considered.