Life Science Partner is pleased to announce the recruitment of Chie Iwaishi to Edwards Lifesciences (NYSE:EW) as Vice President, International Regulatory and Clinical Affairs, where she will lead the expansion of this Irvine-based company in the Japan and Asia-Pacific region.
Iwaishi’s three decades of leadership in regulatory and clinical affairs will be an invaluable asset for Edwards Lifesciences, a global leader in in patient-focused medical innovations for structural heart disease, critical care and surgical monitoring. The company’s heart valve offerings encompass both surgical and transcatheter therapies for heart valve replacement and repair. In addition, Edwards’ pipeline of future technologies is focused on the less invasive repair or replacement of the mitral and tricuspid valves of the heart, which are more complex and more challenging to treat than the aortic valve that is currently the focus of many of the commercially approved valve technologies.
Iwaishi is a distinguished expert in regulatory and clinical affairs, with particular expertise in Japan, China, and the broader Asia-Pacific region. She possesses keen knowledge of the regulatory and cultural paradigms, launched the first drug eluting stent in China, and has considerable senior global leadership experience and business acumen. In her new role, she will spearhead Edwards Lifesciences’ regulatory and clinical programs in Asia, which the company has identified as a key strategic initiative.
“Iwaishi’s deep understanding of regulatory affairs, with many successful PMAs and 510ks, and her well-practiced leadership of large globally-dispersed teams will be a tremendous asset to Edwards Lifesciences as they continue to expand on a global stage,” notes Tom Callaway, President and Founder of Life Science Partner.
Iwaishi joins Edwards Lifesciences from Abbott (formerly Alere Inc.), a rapid point-of-care diagnostic tests manufacturer, where she served as Vice President, Regulatory Affairs Asia Pacific and led their global strategy development and regulatory compliance in Japan, China, Korea and India. She also led the regulatory diligence for Alere’s $1.3 billion acquisition. Earlier in her career, Iwaishi served in regulatory affairs roles of escalating responsibility, working primarily with Class II and Class III medical devices in the cardiovascular space.
About Life Science Partner Executive Search
Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.