Raje Devanathan

Certified Regulatory Affairs and Quality Assurance professional with experience in Medical devices, IVD, SaMD, AIML, Companion diagnostics, Robotic devices combination products in EU, Health Canada, FDA, APAC, TGA/NZ markets. As an accomplished SME Leader, I bring extensive expertise in regulatory and quality, driving innovative solutions and ensuring excellence in medical devices. With a keen eye for detail and a passion for continuous improvement, I have successfully led cross-functional teams in delivering complex projects and achieving organizational objectives. As a hands-on Technical Dossier expert, I possess extensive experience in preparing and managing regulatory submissions and overseeing quality aspects. Demonstrated experience with Design Controls, CAPA, and Purchasing Controls as per 21 CFR Part 4. In-depth knowledge of medical device regulations including 21 CFR Part 820, EU Medical Device Regulation, and ISO 13485:2016. Proven track record in Risk Management according to ISO 14971:2019. Familiarity with IEC 62304: Medical Device Software Life-Cycle Processes. Dynamic Director oversees every facet of production with strong project management and decision-making skills. Brings comprehensive knowledge of medical device, design, development, production writing, planning, and technical operations. Skilled at coordinating production plans and personnel resources to complete work under tight deadlines. Strategic-thinking individual experienced in turning low-performing organizations into top revenue producers. Offering engaging and pleasant personality with expertise improving customer relationships.

• Mastering Regulatory Approvals in New Orphan Drug Markets, 06/2015, DIA 2015 Annual Meeting
• Health Authority: Dispute Resolution Processes in US, Canada and Chinese Taipei, 10/27/2015, Regulatory Convergence 2015
• Transparency and Oversight: Premarket Transparency in the Review of Health Products, 10/27/2015, DIA Canada 2015 Annual Meeting
• A Global Update on Orphan Drug, 06/2015, DIA 2015 Annual Meeting
• Best Practices for Orphan Drug Designation and Regulatory Approvals in New Markets, 10/27/2015, Regulatory Convergence 2015