N N

N N Email and Phone Number

R @
N N's Location
Rockville, Maryland, United States, United States
About N N

Clinical trial, clinical research, medical device regulatory affair, and regulatory medical reviewer in drug and medical device. Goals: I am actively looking for a job since my contract project is almost completed. I want to be a successful regulatory affair professional with passion.Specialties: US and EU medical device and pharmaceutical regulatory affairs

N N's Current Company Details
FDA

Fda

R
N N Work Experience Details
  • Fda
    Withdraw
    Fda Apr 2009 - Present
    • Reviewed safety and efficacy
  • Osmetech Molecular Diagnostics Inc.
    Regulatory Affair Specialist And Associate Scientist
    Osmetech Molecular Diagnostics Inc. Jan 2008 - Apr 2009
    Developed protocol of DNA extraction from human blood samples for nucleic acid assay and medical product development. Performed DNA alignment and analyzed DNA sequences for medical diagnostic product development. Prepared IDE, PMA, QSR, ISO 13485, MDR/vigilance reporting, CAPA, process control, document control, design control, QA/QC, audit, SOPs, and 510k documentation and submitted to FDA. Executed team management and supervision; review relevant scientific publications.
    View
  • Harvard Unversity Medical School/Mgh
    Instructor In Medicine And Clinical Trial Manager
    Harvard Unversity Medical School/Mgh Apr 2005 - Jan 2008
    • Designed, performed and developed autoimmune diabetes clinical trial biomarkers and automation to screen new biological products and monitor PK/PD in vitro, prepare documentation for IDE and IND submission. • Performed GLP and GCP, CTA, SOPs MDR/ vigilance reporting, CAPA, process control, document control, design control, and quality control.

N N Education Details

  • Harvard University Medical School
    Harvard University Medical School
    Immunology
  • School Of Medicine, University Of Louisville
    School Of Medicine, University Of Louisville
    Neurobiology
  • Norman Bethune College Of Medicine, Jilin University
    Norman Bethune College Of Medicine, Jilin University
    Medicine

Frequently Asked Questions about N N

What company does N N work for?

N N works for Fda

What is N N's role at the current company?

N N's current role is R.

What schools did N N attend?

N N attended Harvard University Medical School, School Of Medicine, University Of Louisville, Norman Bethune College Of Medicine, Jilin University.

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