Kathryn Becker

Kathryn Becker Email and Phone Number

FDA Strategy Consultant | Medical Devices @ Translational Science Solutions LLC
charleston, south carolina, united states
Kathryn Becker's Location
Charleston, South Carolina, United States, United States
Kathryn Becker's Contact Details

Kathryn Becker personal email

n/a
About Kathryn Becker

⇒ Independent consultant specializing in the development and execution of business-minded regulatory strategies to support FDA marketing authorization for medical device and digital health products. ⇒ Regulatory navigator who develops and guides strategic communications and related FDA submissions on behalf of clients throughout the product development and commercialization pathway.⇒ Helps client determine optimal regulatory and business positioning new of products, anticipate and exceed regulatory requirements, and obtain feedback and buy-in from regulators to reduce regulatory risk, minimize uncertainty, and ultimately expedite patient access to important new products.

Kathryn Becker's Current Company Details
Translational Science Solutions LLC

Translational Science Solutions Llc

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FDA Strategy Consultant | Medical Devices
charleston, south carolina, united states
Website:
tss-consult.com
Employees:
1
Kathryn Becker Work Experience Details
  • Translational Science Solutions Llc
    Founder + Principal
    Translational Science Solutions Llc Jun 2014 - Present
    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 of health information technology, physical rehabilitation, wound care, neurology, metabolic disease, vascular medicine, orthopedics, women's health, and digital health.• 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 exceed FDA regulatory requirements. • 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, investigational device exemption (IDE) applications, 510(k) premarket notification submissions, premarket approval (PMA) applications, requests for designation (RFD), quality systems inspection support, and submission of comments to the docket for new proposed rules or guidance documents.• 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 FDA buy-in to reduce regulatory risk and expedite the product commercialization pathway.• Current President of SCBio Foundation and former member of SCBIO Board of Directors (Executive Committee; Annual Conference Co-Chair)
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  • Precision For Medicine
    Senior Consultant | Translational And Regulatory Sciences
    Precision For Medicine Feb 2013 - Dec 2018
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  • Nsf International
    Practice Manager, Pharmaceuticals And Biologics
    Nsf International Jul 2011 - Feb 2013
    Washington D.C. Metro Area
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  • Becker & Associates Consulting, Inc.
    Research Associate
    Becker & Associates Consulting, Inc. Jun 2009 - Jul 2011
    Washington D.C. Metro Area
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  • Davidson College
    Department Of Neuroscience
    Davidson College Aug 2006 - May 2009
    Davidson, Nc
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  • Glaxosmithkline
    Summer Talent Identification Program Intern, Biology Drug Discovery, Department Of Metabolic Disease
    Glaxosmithkline May 2007 - Aug 2007
    Research Triangle Park, Nc
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  • Medical University Of South Carolina
    Summer Intern, Department Of Neuroscience
    Medical University Of South Carolina Apr 2004 - Aug 2004
    Charleston, Sc
    View

Kathryn Becker Skills

Fda Regulatory Affairs Fda Submissions Fda Strategy Biotechnology Medical Devices Regulatory Strategy Development Regulatory Analysis Program Management Regulatory Submissions Neuroscience Life Sciences Quality System Pharmaceutical Industry Clinical Research Capa Gmp Drug Discovery Research Lifesciences Quality Assurance Gxp Molecular Biology Biochemistry Clinical Trials Fda Interactions Entrepreneurship U.s. Food And Drug Administration Regulatory Requirements Regulatory Intelligence Regulatory Interactions

Kathryn Becker Education Details

Frequently Asked Questions about Kathryn Becker

What company does Kathryn Becker work for?

Kathryn Becker works for Translational Science Solutions Llc

What is Kathryn Becker's role at the current company?

Kathryn Becker's current role is FDA Strategy Consultant | Medical Devices.

What is Kathryn Becker's email address?

Kathryn Becker's email address is ka****@****ine.com

What schools did Kathryn Becker attend?

Kathryn Becker attended The Johns Hopkins University, Davidson College.

What skills is Kathryn Becker known for?

Kathryn Becker has skills like Fda, Regulatory Affairs, Fda Submissions, Fda Strategy, Biotechnology, Medical Devices, Regulatory Strategy Development, Regulatory Analysis, Program Management, Regulatory Submissions, Neuroscience, Life Sciences.

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