David Coulter Ma Pmp Csm
About David Coulter Ma Pmp Csm
David Coulter Ma Pmp Csm is the Senior Director of Global Labeling and MDR Operations at Teleflex Incorporated in Morrisville, North Carolina, with extensive experience in project management and regulatory compliance in the medical device industry.
Title and Current Position
David Coulter Ma Pmp Csm is the Senior Director of Global Labeling and MDR Operations at Teleflex Incorporated. He is based in Morrisville, North Carolina, United States. In this role, he leads the integration of PLM, ERP, and UDI systems with labeling systems to create a state-of-the-art global labeling organization.
Professional Experience
David has held multiple senior-level positions throughout his career. Prior to his current role at Teleflex Incorporated, he was Head of Project Management for Interventional Urology at Coloplast from 2017 to 2020 in Greater Minneapolis-St. Paul Area. He also worked at Harland Medical Systems, Inc. as Senior Director of Operations and Business Operations Manager in Eden Prairie, MN. His other notable roles include Senior Program Manager at ASTORA Women’s Health and American Medical Systems, and Program Manager at 3M Person Safety Division. Additionally, he served in managerial roles at Arizant Healthcare, Africa Coffee Company, Mission Aviation Fellowship, and Neoligaments.
Education and Expertise
David holds a Master of Arts (M.A.) in International and Intercultural Communication from Wheaton College and a Bachelor of Applied Science (B.A.Sc.) in Construction Engineering from East Tennessee State University. He has expertise in UDI and EUDAMED development, global connection systems, Class 3 PMA, FDA advisory panels, 510K submissions, and ISO risk management. He is an advocate for Agile Scrum methodologies in project management.
Key Projects and Initiatives
Throughout his career, David has led over 18 product development projects, including the commercialization of 8 products generating over $400 million in revenue. He has successfully managed large, diverse teams and collaborated across multiple corporate departments to develop effective solutions in prototyping, sourcing parts, human resources, and capital purchases.
International Experience
David has 15 years of international experience in logistics management and business management. He has worked in various regions including Tanzania and the United Kingdom. His roles required him to manage logistics, operations, and project management, further enhancing his global perspective and cross-cultural communication skills.