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Headshot of Vickie L Anderson
Vickie L Anderson
Request this mentor

Meeting Preference: Phone, Video

Languages: English

How I Can Help You

I can assist you in complying with the food and drug regulations and FD&C Act covering medical devices that are marketed and distributed within the United States. I have over 39 years of experience in auditing quality management systems (includes applicable procedures, applicable documentation), medical device labeling, promotional/advertisement labeling, 510(k) and Premarket submissions, clinical studies, imported medical devices, reviewing establishment registrations and medical device listings. I achieved and maintained medical device level II and medical device auditor (more than 15 years); and worked directly with the State Food and Drug Branch (Medical device Section). I maintained a supervisor position reviewing completed work products (foods, pharmaceuticals, bioresearch monitoring) and program management (medical devices) where I reviewed completed work products of Consumer Safety Officers (Investigators); determined the yearly medical device establishment workplans; made presentations to industry organizations; and for 5 years, taught business courses at a local community college.

Areas of Expertise

  • Government Regulations
  • Product Development

Industry Experience

  • Education
  • Manufacturing
  • Professional Services
  • Wellness, Healthcare, & Home Health
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CONNECT
712 H St NE PMB 98848
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Washington, DC 20002
(800) 634-0245

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