Tag Archive for: AGA Medical

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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Maria Koullick, PhD, joins AGA Medical as Senior Director of Clinical Affairs

Life Science Partner recruits former Clinical Affairs Executive at ATS Medical, Inc.

Life Science Partner announces the recruitment of Maria Koullick, PhD, a senior clinical trials executive, to AGA Medical to become Senior Director of Clinical Affairs for the company.

AGA Medical Corporation 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.

Koullick comes to AGA Medical from ATS Medical, a Minneapolis-based company which was recently acquired by Medtronic.  She directed the strategy and executed the company’s clinical programs for surgical valves, repair products and surgical ablation technologies.

Previously, Koullick held similar roles of increasing responsibility at Medtronic’s Cardiac Rhythm Disease Management and Neurological Divisions.

“Maria has a unique international clinical research trajectory – from the Cardiovascular Surgery Center in Moscow to the National Cardiovascular Surgery Center in Osaka to Medtronic,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Her metric-driven skills emerge from her PhD in Biomedical Engineering, but she has also demonstrated her ability to build and lead a team that accomplishes difficult goals.

She will serve the company well in its mission to bring lasting improvements for patients with cardiovascular defects and peripheral vascular disease.”

Koullick earned her Bachelor and Master of Science degrees in Organic Chemistry from the University of Chemical Technology in Moscow, Russia.  She completed her PhD in Biomedical Engineering at the Bakulev Cardiovascular Surgery Center.

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Pam Simons joins AGA Medical as Senior Director of Clinical Affairs

Life Science Partner recruits former Vice President, Clinical and Regulatory Affairs at Uptake Medical

Life Science Partner announces the recruitment of Pam Simons, an experienced medical device clinical and regulatory executive, to AGA Medical to become Senior Director of Clinical Affairs for the company.

AGA Medical Corporation 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.

In Simons’ previous role at Uptake Medical, a Seattle-based company developing non-surgical treatment for emphysema and COPD, she was responsible for worldwide efforts in clinical and regulatory affairs for the company.  Previously, Simons held a similar role at First Circle Medical where she led development and execution of the company’s global clinical development from Phase I to commercialization.

“Simons is a high energy individual with a demonstrated track record of success in development and execution of clinical strategy and regulatory approval for innovation Class II medical devices,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “With her passion and experience, she will serve AGA Medical well in its mission to bring lasting improvements for patients with cardiovascular defects and peripheral vascular disease.”

Simons earned her Bachelor of Science degree in Radiologic Sciences from the University of North Carolina at Chapel Hill.

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