22-year track record of success in multiple areas including regulatory, operations, med-tech facility development and management, product design/development, and project management. I possess expertise in applying best business practices to ensure efficient operations of organizational services and processes to increase productivity while controlling costs. As a skilled project manager in technical facility development, I planned and completed high-profile initiatives on time and on budget. I am also a proven team leader with a history of training and developing efficient cross-functional teams. A key driver to my professional success has been applying my interpersonal skills to effectively interact and build partnerships with stakeholders, senior leaders, associates, and other third parties. I am knowledgeable of 21 CFR Part 820 (FDA), EU-MDR, ISO: 13485:2016(Medical Devices)- MDSAP, ISO: 9001 and ISO: 17025(Test Lab Standard). I was granted two US Patents for developing medical devices.