Shani Smith Email and Phone Number
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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.
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Senior Regulatory Program ManagerFda Feb 2022 - Present -
Research OfficerFda Jan 2016 - Feb 2022Washington D.C. Metro AreaIn 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. -
Senior Regulatory ReviewerFda Jun 2011 - Jan 2016Silver Spring MdAs 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 -
ChemistFda Mar 2004 - Jun 2011Laurel, MdPerformed 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
Shani Smith Education Details
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Cybersecurity Policy And Management -
North Carolina State UniversityChemistry -
Tennessee State UniversityChemistry
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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Shani Smith
Public Relations Student Attending Howard University|Cathy Hughes School Of Communications Annenberg Honors StudentWashington, Dc -
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4sedgwickcms.com, yahoo.com, sedgwick.com, sedgwick.com
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