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Years of Experience
Date Last Verified
Regulatory Affairs Associate The candidate implements BDPI domestic and international regulatory affairs procedures. Acts as a liaison to Corporate Law Department, providing requested information. Supports senior Regulatory personnel prepare new product marketing submission for the FDA (510k, PMA). Maintains all Regulatory Affairs documentation. Assists as a Regulatory representative on New Product Development teams. Supports all international Regulatory requests. Sends out notifications of change to the Notified Body as required. Supports divisional and corporate litigation requests as needed. Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements. Performs on special projects as required. Excellent problem solving and analytical skills is essential. Good written and oral communication skills is essential. Must have a Bachelors Degree in Law, Engineering, Biology or one of the Life Sciences. Must have 0-1 year of experience in a regulatory or documentation environment or related field. Knowledge of federal medical device regulations is essential.
Job ID 2018-11764
Company infoHiring Coordinator