Tag Archive for: Clinical and Regulatory Affairs

Ross Segan, MD, to Become FDA CDRH’s Office Director, Product Evaluation & Quality

Life Science Partner has recruited Ross (Rusty) Segan, MD, formerly Chief Medical Officer of Olympus and Integrated Leader, Pre-Clinical, Clinical, and Medical Affairs at DuPuy Synthes, to the FDA to become Director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health (CDRH).

Segan’s New Role and Responsibilities at the FDA

In this role, Dr. Segan is responsible for setting the strategy and overseeing Device-Specific Offices, the Office of Clinical Evidence and Analysis, and the Office of Regulatory Programs. His leadership ensures quality end-to-end device evaluation and consistent interpretation and application of regulatory policy and guidance.

Ross "Rusty" Segan, MD, FDA CDRH's Office Director, Product Evaluation & Quality

With his extensive background in medical and scientific affairs, Dr. Segan brings a wealth of experience from his global leadership roles at Olympus, Johnson & Johnson, and Covidien, where he led the development and implementation of clinical and regulatory strategies that significantly improved clinical outcomes and upheld patient safety.

Career Highlights and Contributions to the Medical Device Industry

Before joining the FDA, Dr. Segan held several prominent positions in the medical device industry. As Chief Medical Officer of Olympus, he was pivotal in driving the company’s medical safety initiatives and fostering innovation across the global portfolio. At Johnson & Johnson’s DuPuy Synthes, he led Pre-Clinical, Clinical, and Medical Affairs for the $9 billion orthopedic and medical device division.

His career also includes leadership roles at Covidien, overseeing a diverse portfolio of clinical studies, healthcare economics, and reimbursement strategies. Across these roles, Dr. Segan consistently demonstrated his ability to integrate business strategy with scientific excellence, driving transformation in medical technologies that improved patient care worldwide.

“Rusty brings a wealth of experience in science, medicine, and, most importantly, organizational leadership,” said Thomas Callaway, MD, Founder of Life Science Partner.  His former colleagues widely praised his management skills, an asset that will help him succeed in leading the teams and infrastructure within the FDA’s CDRH. 

Dr. Segan’s educational background complements his extensive career in the medical technology industry. He earned his Medical Doctor degree from UMDNJ-Robert Wood Johnson Medical School and holds a Master of Business Administration with specializations in Entrepreneurship, Innovation, and Leadership from New York University’s Stern School of Business.

Before his medical education, Dr. Segan earned a Bachelor of Science from Salisbury State University and a Master of Science in Athletic Training from West Virginia University. 

His clinical training includes general surgery residencies at Thomas Jefferson University Hospital and Cooper Hospital/University Medical Center and a clinical fellowship in minimally invasive surgery at the University of Maryland.

This diverse academic background has equipped Dr. Segan with a unique combination of medical, business, and leadership expertise, enabling him to excel in advancing healthcare technology and regulatory practices globally.

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

FDA Regulatory Leadership For Medtech/IT Convergence

Life Science Partner has partnered with the FDA to recruit leaders that can create innovative pathways for early-stage companies to be better prepared for the regulatory review and clearance process. In close collaboration with Jeff Shuren, MD, JD, Head of the Center for Devices and Radiological Health (CDRH) for the FDA, Life Science Partner recruited Doug…

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Chie Iwaishi Joins Edwards Lifesciences as Vice President, International Regulatory & Clinical Affairs

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.

Chie Iwaishi

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.

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K2M Recruits Caitlyn Seidl to be Director, Clinical & Regulatory Affairs

Life Science Partner is pleased to announce the recruitment of Caitlyn Seidl to K2M, where she will serve as Director, Regulatory & Clinical Affairs.

Based in Leesburg, Virginia, K2M is a medical device company focused on creating tools and implants for minimally-invasive spine surgery. The company is a leader in the 3D printing of spinal implants for deformity (especially scoliosis), trauma, and tumor operations. Reporting to the Senior Vice President of Global Quality and Regulatory Affairs, Seidl will be responsible for directing global clinical outcomes research programs and the global regulatory process for K2M’s product portfolio.

Previously, Seidl served as Manager, Clinical Affairs for the Critical Care division of Edwards Lifesciences, a leader in artificial heart valves and related technologies. Seidl has also held clinical affairs leadership positions with Exactech (orthopedic devices), Axogen (biologics), and Cardioquest (cardiovascular research). She brings to K2M more than a decade of clinical and regulatory affairs leadership including trials in spinal orthopedics.

“Caitlyn impressed us as a leader with both the technical acumen in clinical trials for spinal orthopedic devices and the team management skills to ensure the group’s clinical studies faithfully convey the value K2M’s technologies bring to patients,” shared Tom Callaway, MD, MBA, President of Life Science Partner. “She will be a great asset to K2M and we look forward to seeing her impact over the coming years.”

Seidly earned her bachelor’s degree in Biomedical Sciences from the University of South Florida.

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.

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Steve McQuillan Joins Medtronic’s AF Solutions as Vice President of Clinical and Regulatory Affairs

Life Science Partner recruits former Lead Director of Clinical Affairs at Boston Scientific Cardiac Rhythm Management Division.

Life Science Partner announces the recruitment of clinical affairs executive Steve McQuillan to Medtronic’s Cardiac Rhythm Disease Management Division (CRDM), the largest and oldest business unit of the global $13.5 billion medical device company.

With the recent acquisitions of Ablation Frontiers and CryoCath Technologies, the newly formed CRDM Business Unit, AF Solutions, brings breakthrough therapeutic choices and tools to physicians and their patients with atrial fibrillation.

In his most recent role at Boston Scientific Cardiac Rhythm Management (CRM) Division, McQuillan was responsible for developing and implementing the CRM and Electrophysiology clinical strategy for all US-based clinical trials.   He had a steady and successful rise through his tenure at the Guidant CRM organization prior joining Boston Scientific.   In his new role, McQuillan will provide strategic leadership, oversight, and overall management of the regulatory and clinical activities for the new atrial fibrillation division.

“McQuillan is a passionate, highly motivated executive with wide-ranging clinical and regulatory experience in the CRM space” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Along with his strong relationships with Electrophysiology thought-leaders worldwide, he will bring strong clinical development leadership and quality execution to Medtronic’s CRDM Division.”

McQuillan received his Bachelor of Arts Degree in Biometry and Statistics from the University of Minnesota, Twin Cities.

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Steve Hamburger, PhD, joins Exoxemis, Inc. as Vice President, Clinical and Regulatory Affairs

Life Science Partner recruits former Oncology Regulatory Officer for Johnson & Johnson, Pharmaceutical and Research & Development.

Life Science Partner announces the recruitment of Steve Hamburger, a global regulatory and drug development executive, to Exoxemis, Inc.

Exoxemis is an early-stage biopharmaceutical research and development company focused on prevention and treatment of serious infections and the significant and growing problem of microbial drug resistance.  The company’s myeloperoxidase (MPO) technology is a versatile platform that can be leveraged into multiple product areas, including medical, biodefense, industrial, veterinary, disinfectant, and agricultural applications.

In Hamburger’s most recent role at J & J, he was responsible for a cross-functional regulatory and drug development team and served as a global regulatory officer for the Oncology and Hematology division.  His portfolio included the key biologic PROCRIT.  Previously, he served in a similar role as the strategic and operational leader for the anti-cancer drug DOXIL.  Prior to his tenure at J & J, Hamburger was Senior Regulatory Research Scientist, Oncology and US Regulatory Affairs for Eli Lilly and Company.

“Steve is an experienced regulatory strategist with a broad therapeutic background in the pharmaceutical industry including the areas of infectious diseases, cardiology and oncology,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “He’s a passionate and self-directed individual with a long track record of successful interactions with key global health authorities that will greatly benefit Exoxemis’ platform and opportunity.”

Hamburger received his Bachelor of Science degree in General Science and Biochemistry from the University of Iowa in Iowa City.   He earned a Master of Science in Biology from Butler University in Indianapolis, Indiana and his PhD in Pharmacology and Toxicology from the Indiana University School of Medicine.

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