Judi Smith

Judi Smith Email and Phone Number

Vice President, Clinical/Regulatory at BioPorto Diagnostics Inc @ Precision for Medicine
Judi Smith's Location
Hydes, Maryland, United States, United States
Judi Smith's Contact Details

Judi Smith personal email

n/a

Judi Smith phone numbers

About Judi Smith

Judi Smith, MS, MT (ASCP), is Vice President, Clinical/Regulatory at BioPorto Diagnostics Inc.Ms. Smith has worked in the medical products regulatory, quality, and clinical trial areas for over 30 years. In that time, she has been responsible for the regulatory submissions and approvals of a multitude of companion diagnostic assays, in vitro diagnostic products, and biological in vitro diagnostic assays, and for the establishment of quality systems for diagnostic products. She has also developed and implemented clinical trials for these products that were used to generate data for the regulatory submissions. She also is on the faculty of the RAPS University as an IVD Subject Matter Expert. As a member of the FDA/Industry Roundtable, Ms. Smith was awarded the FDA Group Recognition Award. She served as President of the Association of Medical Diagnostics Manufacturers for 10 years. This organization is dedicated to the in vitro diagnostic industry and provides educational programs with the FDA/CDRH/Office of In Vitro Diagnostics and Radiological Health.Ms. Smith received her Bachelor of Science from Temple University and her Master of Science from Medical College of Pennsylvania.

Judi Smith's Current Company Details
Precision for Medicine

Precision For Medicine

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Vice President, Clinical/Regulatory at BioPorto Diagnostics Inc
Judi Smith Work Experience Details
  • Bioporto Diagnostics Inc.
    Vice President, Clinical/Regulatory
    Bioporto Diagnostics Inc. Aug 2018 - Present
  • Precision For Medicine
    Vp, In Vitro Diagnositcs And Quality
    Precision For Medicine May 2013 - Present
    Bethesda, Md, Us
    Regulatory strategies, regulatory submissions, Informed Consent for ethical collections, clinical trials, and quality systems for IVDs.
  • Judi Smith Llc
    Principal
    Judi Smith Llc May 2000 - May 2013

Judi Smith Skills

Clinical Trials Medical Devices Regulatory Submissions Biotechnology Life Sciences In Vitro Quality System Medical Diagnostics Technology Transfer Biopharmaceuticals Validation Clinical Development U.s. Food And Drug Administration Glp Gmp Regulatory Affairs Sop V&v Fda/oir Fda Hardware Diagnostics Clinical Research Commercialization Pharmaceutical Industry Iso 13485 Oncology Infectious Diseases Lifesciences Capa Design Control Medicine Product Launch Manufacturing Product Development Capital Equipment Diagnostics

Judi Smith Education Details

  • Medical College Of Pennsylvania
    Medical College Of Pennsylvania
    Medical Technology/Clinical Chemistry
  • Temple University
    Temple University
    Medical Technology

Frequently Asked Questions about Judi Smith

What company does Judi Smith work for?

Judi Smith works for Precision For Medicine

What is Judi Smith's role at the current company?

Judi Smith's current role is Vice President, Clinical/Regulatory at BioPorto Diagnostics Inc.

What is Judi Smith's email address?

Judi Smith's email address is ju****@****ine.com

What is Judi Smith's direct phone number?

Judi Smith's direct phone number is (240) 654*****

What schools did Judi Smith attend?

Judi Smith attended Medical College Of Pennsylvania, Temple University.

What skills is Judi Smith known for?

Judi Smith has skills like Clinical Trials, Medical Devices, Regulatory Submissions, Biotechnology, Life Sciences, In Vitro, Quality System, Medical Diagnostics, Technology Transfer, Biopharmaceuticals, Validation, Clinical Development.

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