Melissa White

Background

About Melissa White

I am passionate about solving complex business problems that mitigate risk, protect business and delight stakeholders. I lead with integrity and empathy, galvanizing talented cross functional global teams delivering transformational change. I hold an MSc in Quality Management and am a certified Project Manager with over 20 years of experience navigating and completing complex projects. Currently, I manage a portfolio of global programs, including the implementation of the EU MDR, UK CA, EU Authorized Representative Change, and UDI for all vision care products. As an experienced Global Director, I have a successful track record in transforming global processes and systems, introducing transformational change, and driving significant improvements. My achievements include: Leading product design changes that resulted sustaining a legacy product on market for a vulnerable patient base. Implementing electronic device history records, enhancing traceability and compliance, enabling future automation and annualized savings of +$500k. Introducing electronic IFUs, reducing paper usage by 50%. Ensuring compliance with new and updated regulations and standards. Overseeing packaging and labeling changes. Streamlining enterprise systems, resulting in a increase in operational efficiency Additionally, I have over 10 years of experience in quality management systems leadership positions within the medical device and pharmaceutical industries. I have a proven history of introducing compliant quality management systems and ensuring successful inspections by Notified Bodies, Regulatory Authorities, and Competent Authorities. Key accomplishments include: Successfully leading multiple Notified Body and Regulatory Authority inspections with zero critical or major findings. Developing and implementing quality management systems that improved audit readiness and compliance. Leading cross-functional teams to achieve ISO 13485, MDSAP, FDA parts 820, 210 and 211 certification. Outside of work, I am a true crime enthusiast who enjoys listening to podcasts and reading both true and fictional crime stories. I also love to travel, with a goal of visiting as many countries as possible to experience and learn about different cultures.