Meg D.

Principal Regulatory Affairs Specialist at ACIST Medical Systems

Meg D. has extensive experience in regulatory affairs, currently serving as a Principal Regulatory Affairs Specialist at ACIST Medical Systems since August 2021, where responsibilities include leading regulatory efforts for product development teams and authoring submissions such as Q-submissions and 510(k) applications. Prior roles include Senior Regulatory Affairs Specialist at Medtronic from August 2015 to August 2021, where Meg led regulatory initiatives for significant device transitions and product developments, alongside managing various regulatory submissions and audits. Earlier experience includes serving as a Regulatory Affairs Specialist at Coloplast Corp, where Meg authored FDA submissions and evaluated advertising materials, as well as roles as a Clinical Research Associate and Coordinator, overseeing multiple study sites and managing clinical data collection. Meg holds a BA in French Studies from the University of Minnesota and is currently pursuing further education at St. Cloud State University and Minneapolis College for Nursing Assistant Certification.

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ACIST Medical Systems

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ACIST Medical Systems, Inc. is a pioneering interventional and diagnostic technology company with a portfolio of advanced products, including the world’s first Rapid Exchange FFR and High Definition IVUS systems. It is also a global market leader in advanced contrast imaging systems for cardiovascular angiography and radiology imaging. Through these products, ACIST is demonstrating its commitment to bringing unique and innovative technologies that simplify cardiovascular procedures and empower clinicians to treat patients with superior care. As part of the Bracco Group, ACIST benefits from the resources of a multinational conglomerate with broad expertise in cath lab technology and a dedication to continuous advancement. Headquartered in Eden Prairie, Minnesota, USA, ACIST has worldwide presence with over 300 direct employees and facilities in Silicon Valley, Maastricht, Shanghai and Tokyo.