Regulatory Affairs Specialist II - (Chicago, IL)

Overview The Regulatory Affairs Specialist is located at C.R. Bard Medical Division in Covington, GA. Summary of Position with General Responsibilities The Regulatory Affairs Specialist is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team. Essential Job Functions Provide regulatory support through the product life-cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents) Prepare 510(k)s, IDEs, PMA and/or international submissions as required Assist in technical interface with FDA and international reviewers and respond to questions Provide the appropriate details to support international product registrations Provide timely review of product labeling and marketing claim for regulatory compliance; approve as directed Provide support required for CE marking activities