| Hyejeoung Lee joins JNPMEDI as a Senior Product Leader to improve regulatory integration and medical device development.
| Expecting to Enhance Competitiveness in Global Clinical Approvals and Market Entry for Medical Devices
JNPMEDI (CEO Kwunho Jeong) announced on the 22nd, the recruitment of Hyejeoung Lee, who owns an extensive experience and an expertise in the full life cycle of the medical device industry. Senior Project Leader Lee is a seasoned expert in overseeing the entire process of medical device projects, from product development to regulatory approvals and global market entry. She will play a key role in directly leading JNPMEDI's medical device initiatives.
Senior Project Leader Lee, began her career at BioSpine, focusing on the development of spinal implants and related surgical instruments. She later held key roles at Genewel Co., Ltd. and Synex Consulting Ltd., where she managed the development and regulatory affairs of various medical devices. Lee has successfully led strategies for obtaining both domestic and international regulatory approvals and facilitating global market entry. Throughout this process, she has navigated the regulatory requirements of authorities such as the U.S. FDA, European CE, Japan's PMDA, and China's National Medical Products Administration (NMPA), driving the commercialization of medical products.
Senior Project Leader Lee has not only overseen regulatory procedures but has also led strategies that integrate the entire product development cycle—from initial development to clinical trials, GMP/ISO13485 (Good Manufacturing Practices and Quality Management System for Medical Devices), new medical technology approvals for insurance coverage, and eventual sales. By doing so, she has successfully navigated complex regulatory environments in multiple countries, building practical strategies for regulatory approvals and market entry.
Senior Project Leader Lee intends to use her experience at JNPMEDI to combine the regulatory and clinical trials divisions, which are now distinct, into a single, integrated project. It is anticipated that this reorganization would increase departmental cooperation and client communication, which will ultimately raise project success rates.
Kwunho Jeong, CEO of JNPMEDI, stated, "The recruitment of Hyejeoung Lee as a Senior Project Leader at JNPMEDI offers a significant opportunity to provide greater value to our clients through a more integrated and systematic approach in the medical device industry. We are confident that her experience and expertise will play a pivotal role in helping our clients achieve their global objectives."
| Hyejeoung Lee joins JNPMEDI as a Senior Product Leader to improve regulatory integration and medical device development.
| Expecting to Enhance Competitiveness in Global Clinical Approvals and Market Entry for Medical Devices
JNPMEDI (CEO Kwunho Jeong) announced on the 22nd, the recruitment of Hyejeoung Lee, who owns an extensive experience and an expertise in the full life cycle of the medical device industry. Senior Project Leader Lee is a seasoned expert in overseeing the entire process of medical device projects, from product development to regulatory approvals and global market entry. She will play a key role in directly leading JNPMEDI's medical device initiatives.
Senior Project Leader Lee, began her career at BioSpine, focusing on the development of spinal implants and related surgical instruments. She later held key roles at Genewel Co., Ltd. and Synex Consulting Ltd., where she managed the development and regulatory affairs of various medical devices. Lee has successfully led strategies for obtaining both domestic and international regulatory approvals and facilitating global market entry. Throughout this process, she has navigated the regulatory requirements of authorities such as the U.S. FDA, European CE, Japan's PMDA, and China's National Medical Products Administration (NMPA), driving the commercialization of medical products.
Senior Project Leader Lee has not only overseen regulatory procedures but has also led strategies that integrate the entire product development cycle—from initial development to clinical trials, GMP/ISO13485 (Good Manufacturing Practices and Quality Management System for Medical Devices), new medical technology approvals for insurance coverage, and eventual sales. By doing so, she has successfully navigated complex regulatory environments in multiple countries, building practical strategies for regulatory approvals and market entry.
Senior Project Leader Lee intends to use her experience at JNPMEDI to combine the regulatory and clinical trials divisions, which are now distinct, into a single, integrated project. It is anticipated that this reorganization would increase departmental cooperation and client communication, which will ultimately raise project success rates.
Kwunho Jeong, CEO of JNPMEDI, stated, "The recruitment of Hyejeoung Lee as a Senior Project Leader at JNPMEDI offers a significant opportunity to provide greater value to our clients through a more integrated and systematic approach in the medical device industry. We are confident that her experience and expertise will play a pivotal role in helping our clients achieve their global objectives."