Support PDF,DOC,DOCX,TXT,XLS,WPD,HTM,HTML fils up to 5MB
Years of Experience
Date Last Verified
ProfileRegulatory Affairs Associate Essential Job Functions: 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.
Qualification and Experience
The candidate should have a Bachelors Degree in Law, Engineering, Biology or one of the Life Sciences. Should have 0-1 year experience in a regulatory or documentation environment or related field. Ability to review, collate and summarize scientific and technical data. Ability to handle master documents, drawings, and specifications with a high degree of confidentiality. Excellent problem solving and analytical skills. Good written and oral communication skills. Knowledge of federal medical device regulations.
Job ID : 2017-10927