Tag Archive for: 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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Susan Alpert, MD, PhD joins Canary Medical as Regulatory Affairs Leader

Former Senior Vice President, Chief Regulatory Officer at Medtronic

As one of the foremost leaders in the complex regulatory arena of medical devices, combination products, and healthcare information, Susan Alpert, MD, PhD, has been recruited by Life Science Partner to serve as the top regulatory advisor for Canary Medical.

Canary Medical has established an innovative portfolio of intellectual property surrounding its CHIRP (Canary Medical Implantable Recording Processor) technology that is transforming the medical field as it allows medical device manufacturers to integrate a 1cc implanted device for wireless data transmission.

“As a seasoned expert within the inner workings of the FDA on healthcare data and appropriate management of patient information, the regulatory role at Canary will be a natural fit for Alpert following her retirement from Medtronic,” states Tom Callaway, MD, President of Life Science Partner.  “Alpert will be an invaluable source for Canary’s rapidly growing company and current leadership team- Bill Hunter, CEO and Jeff Gross, CTO.

Susan completed her bachelor’s degree at Barnard College, Columbia University in New York City and holds a master’s degree and Ph.D. in Biomedical Sciences from New York University.

She received her medical degree from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National Medical Center in Washington, D.C.

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Lisa Becker joins AGA Medical as Senior Director of Regulatory Affairs

Life Science Partner recruits former Director, Worldwide Regulatory Affairs at Boston Scientific

Life Science Partner announces the recruitment of Lisa Becker, a senior medical device regulatory executive, to become Senior Director of Regulatory Affairs for the AGA Medical Corporation.

AGA Medical is a Plymouth, Minnesota based medical device company focused on the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease. AGA Medical was recently acquired by St. Jude Medical.

In her most recent role at Boston Scientific, Becker served as Director of Worldwide Regulatory Affairs for the Cardiac Rhythm Management Division.  During Becker’s long tenure at Guidant/Boston Scientific, she served in numerous regulatory leadership roles of increasing responsibility for the company.  Becker’s early career was spent in the U.S Air Force as a Military Personnel Flight Commander.

“Lisa is an articulate and passionate leader who has built both small highly efficient regulatory teams and managed large complex international regulatory organizations,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “She has an impressive track record of creating innovative systems which utilize data-driven metrics to accelerate the regulatory approval process.”

Becker earned a Bachelor of Science degree in Organizational Behavior with General Engineering Minor from the United State Air Force Academy and a Master of Science degree in Human Resource Management and Information Systems from Chapman University.

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