Dawn Norman is a seasoned executive at MRC Global, where she serves as a Partner, leveraging her extensive expertise in the medical device industry to drive innovative solutions for clients navigating the complex landscape of regulatory compliance and quality assurance. With a robust background in...
Dawn Norman is a seasoned executive at MRC Global, where she serves as a Partner, leveraging her extensive expertise in the medical device industry to drive innovative solutions for clients navigating the complex landscape of regulatory compliance and quality assurance. With a robust background in business development, Dawn excels in guiding organizations through the intricacies of regulatory affairs, particularly in the realms of Medical Devices, Tissue, and Biologics. Her proficiency in Quality Systems, including 21 CFR 820 and ISO 13485:2016, positions her as a pivotal resource for companies seeking to enhance their operational frameworks and ensure compliance with stringent industry standards.
At MRC Global, Dawn is instrumental in leading key projects that focus on the development and submission of Class I, II, and III U.S. Food and Drug Administration (FDA) applications, as well as EU Technical Files. Her hands-on approach to clinical consulting allows her to tailor strategies that align with the unique needs of diverse clientele, from startups to established enterprises. Dawn’s commitment to excellence is further exemplified through her adeptness in Design Control, Change Control, and the implementation of Standard Operating Procedures (SOPs) that foster a culture of quality and compliance.
Dawn's strategic insights and collaborative spirit make her a trusted partner for organizations aiming to navigate the regulatory landscape effectively. Her ability to synthesize complex information into actionable strategies not only enhances project completion rates but also empowers clients to achieve their long-term business objectives in the ever-evolving life sciences sector. With a keen eye for detail and a passion for innovation, Dawn Norman continues to shape the future of medical device consulting at MRC Global.
