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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 analy...