Vivek D.

About Vivek D.

Passionate Professional Empowering Regulatory Excellence in the Medical Device Industry Hi, I\'m Vivek Dabi, a committed professional with over 8 years of experience in the medical device industry, focusing on Quality Management, Regulatory Affairs, and Business Intelligence. Throughout my career, I have championed regulatory compliance and operational efficiency while contributing to the successful development, launch, and maintenance of high-quality medical devices. Key Expertise: Global Regulatory Compliance & Documentation: In-depth experience with 510(k) submissions, UDI, Health Canada, EUDAMED, and CDSCO and Row submissions. Well-versed in the requirements of ISO 13485, US FDA, EU MDR/IVDR, MDSAP, QSR and BIS standards. Certified Lead & Internal Auditor: Proven ability to audit processes and systems, identify improvement areas, and implement corrective actions, ensuring continuous quality enhancement. Medical Device Compliance & Risk Management: Hands-on experience ensuring compliance with international medical device regulations, including EU MDR, EU IVDR, ANVISA, TGA, PMDA, FDA, ISO 13485, and IMDR. New Product Development (NPD) & Project Management: Successfully led NPD teams, migrated products to manufacturing, and optimized product lifecycle processes, ensuring adherence to IEC 60601, IEC 62304, and other international standards. Business Intelligence & Operations Optimization: Leveraging tools like SAP Business One, Jira, Trello, and others to streamline operations and make data-driven decisions that drive efficiency and organizational success. 🤝 Cross-functional Leadership: I take pride in my ability to lead and collaborate across R&D, manufacturing, regulatory affairs, and quality teams to create innovative solutions and ensure smooth regulatory submissions. Educational Background: I hold an MBA, providing a strategic business perspective, and a B.Tech in Electronics and Communication Engineering, which gives me a strong technical foundation to effectively navigate complex regulatory challenges. Let’s Connect! I’m passionate about driving regulatory compliance, fostering innovation, and contributing to the success of medical device organizations. Whether you’re looking to discuss industry trends, regulatory challenges, or collaborate on a new project, feel free to reach out. Together, we can make a meaningful impact in the medical device industry. Let’s start a conversation that could lead to exciting opportunities and innovations in medical devices and regulatory affairs!

Experience

1. Regulatory Affairs Lead

   Positivity

   May 2024 — Present · Bengaluru, IN