Meredith Vanderbilt, JD, RAC

Experience

• 

  Elan Pharmaceuticals

  Jan 1999 - Jan 2001

  Industrial Enigneer

  Participated in process validation of complex packaging system for inhalable insulin. Led all process risk activities using pFMEA process.

• 

  ZimVie Dental

  Mar 2001 - Jul 2006

  Manufacturing Engineering Manager

  ZimVie is a global life sciences leader in the dental market that develops, manufactures, and delivers a portfolio of products and solutions to support dental tooth replacement and restoration procedures. • Responsible for a $1 Million department dedicated to process improvements to bring the Cost of Goods Sold into alignment with company objectives. • Lead for manufacturing in all Corrective and Preventive Action (CAPA) projects and Root Cause Analysis activities. • Led the Quality Improvement Plan Team from 2001 to 2003 to successfully resolve all FDA audit observations. • Manufacturing representative of several product development teams, and participated in all Design History File activities, including risk mitigation. Show less

• 

  Atlas Spine

  Jul 2006 - Dec 2011

  Vice-President of Engineering, Quality, & Regulatory Affairs

  Atlas Spine creates, manufactures, and markets minimally invasive implants and instrument systems for the treatment of various pathologies of the spine. Atlas is a design resource for spine surgeons and some of the largest players in the medical device industry. Its mission is to develop and market innovative, cost-effective, high-quality, and clinically efficacious systems. Working closely with some of today's top spine surgeons, Atlas is developing disruptive technology and forging the future of spine care. • Led the company through increasingly difficult product commercialization cycles including: o development of the patent portfolio o 510(k) filings o design history files o quality management system and activities • Led the Scientific Advisory Board made up of surgeons and industry leaders to define the future requirements of the spinal market.• Hired as vice president of engineering and promoted to include the quality and regulatory affairs department. Show less

• 

  Empirical Technologies Corp.

  Nov 2010 - Nov 2024

  Director of Consulting (RA/QA)

  Providing 510(k), breakthrough device designation, emergency use authorization, and other FDA filings, quality system development, sterilization validation, and general consulting for potential medical device developers and manufacturers in order to meet FDA and ISO requirements. The Empirical group of companies strives to help you gain clearance or approval and keep it through the years as your company grows.Regulatory Affairs Certification (RAC) through Regulatory Affairs Professionals Society (RAPS).Certified Quality Auditor (CQA) through American Society for Quality (ASQ). Show less

• 

  Bartko Pavia LLP

  Nov 2024 - now

  Special Counsel