Shani Smith

Shani Smith Email and Phone Number

Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP. @ FDA
silver spring, maryland, united states
Shani Smith's Location
Glen Burnie, Maryland, United States, United States
Shani Smith's Contact Details

Shani Smith personal email

n/a
About Shani Smith

Results driven leader with 18 years of regulatory experience which includes evaluating analytical and manufacturing data of dietary supplements to ensure quality and safety, accessing biocompatibility and sterilization procedures of medical devices, communicating with international standards organization regarding FDA policy on medical devices, and adhering to quality in regulatory science by following good laboratory practice (GLP). Acquired cybersecurity policy experience to implement risk management strategies to protect critical infrastructure sectors such as healthcare, financial, and critical manufacturing.My research and expertise have allowed the Office of Compliance and Office of the Chief Counsel to enforce regulatory actions per FDA statutes.

Shani Smith's Current Company Details
FDA

Fda

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Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP.
silver spring, maryland, united states
Website:
fda.gov
Employees:
14770
Shani Smith Work Experience Details
  • Fda
    Senior Regulatory Program Manager
    Fda Feb 2022 - Present
  • Fda
    Research Officer
    Fda Jan 2016 - Feb 2022
    Washington D.C. Metro Area
    In this position I am responsible for evaluating the chemistry sections of New Dietary Ingredient Notifications submitted to the FDA. Additionally, I evaluate evidence submitted by the FDA Office of Compliance to determine whether or not dietary supplements on the market are adulterated.
  • Fda
    Senior Regulatory Reviewer
    Fda Jun 2011 - Jan 2016
    Silver Spring Md
    As a Senior Regulatory Reviewer, I had the following responsibilities: • Performed comprehensive, scientifically-based pre-market application reviews and evaluations of infection control devices. • Provided sterilization and biocompatibility consults for 510(k) submissions • Provided sterilization consults for CDRH Office of Compliance inquiries. • Evaluated bench and animal testing submitted by industry in the pre-market application. • Prepared… Show more As a Senior Regulatory Reviewer, I had the following responsibilities: • Performed comprehensive, scientifically-based pre-market application reviews and evaluations of infection control devices. • Provided sterilization and biocompatibility consults for 510(k) submissions • Provided sterilization consults for CDRH Office of Compliance inquiries. • Evaluated bench and animal testing submitted by industry in the pre-market application. • Prepared correspondence to industry recommending clearance of infection control devices based upon data submitted by industry. • Served as an FDA sterilization product liaison to a global medical device standard body (AAMI/ISO). Show less
  • Fda
    Chemist
    Fda Mar 2004 - Jun 2011
    Laurel, Md
    Performed analytical chemistry methods such as LC-MS/MS to detect drug residues in food producing animals. Became first author of article “Simultaneous screening and confirmation of multiple classes of drug residues in fish by liquid chromatography-ion trap mass spectrometry” accepted for publication in Journal of Chromatography A.

Shani Smith Skills

Chemistry Laboratory Leadership Management Problem Solving Statistics Strategic Planning Teaching Team Building Analysis Coaching Microsoft Office Nonprofits Powerpoint Research Strategy Team Leadership Analytical Skills Public Speaking

Shani Smith Education Details

Frequently Asked Questions about Shani Smith

What company does Shani Smith work for?

Shani Smith works for Fda

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

Shani Smith's current role is Results driven leader with 20 years of FDA experience which includes drug master files, dietary supplements, medical devices, and GLP..

What is Shani Smith's email address?

Shani Smith's email address is sh****@****hhs.gov

What schools did Shani Smith attend?

Shani Smith attended University Of Maryland University College, North Carolina State University, Tennessee State University.

What skills is Shani Smith known for?

Shani Smith has skills like Chemistry, Laboratory, Leadership, Management, Problem Solving, Statistics, Strategic Planning, Teaching, Team Building, Analysis, Coaching, Microsoft Office.

Who are Shani Smith's colleagues?

Shani Smith's colleagues are Svetlana Petrovskaya, Julie F., Jill Lindstrom, Alan Centi, Tiffany Limerick, Jena Weber, Anthony Ciavarella.

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