Kathryn Becker Email & Phone Number

Charleston, South Carolina Area

• Develops and executes business-minded regulatory strategies related to U.S. Food and Drug Administration (FDA) marketing authorization for medical devices and other life science products, including those in the fields.
• Assists medical device companies and entrepreneurs in assessing potential regulatory pathways for pioneering medical devices and determining the most efficient and advantageous positioning for new products to meet and.
• Guides the strategy and development of communications with and submissions to the FDA on behalf of clients, including Pre-Submission (Pre-Sub) meeting requests, Breakthrough Device Designation (BDD) requests.
• Utilizes in-depth knowledge of science, regulatory affairs, business planning, and product management background to develop product development plans (e.g., pre-clinical and clinical evidence development) and obtain.
• Current President of SCBio Foundation and former member of SCBIO Board of Directors (Executive Committee; Annual Conference Co-Chair)

Washington D.C. Metro Area

Washington D.C. Metro Area

Davidson, NC

Research Triangle Park, NC

Charleston, SC

Masters

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