minneapolis, Minnesota
Records Coordinator Job Opening in minneapolis, Minnesota - Records Coordinator A leading manufacturer of medical devices is seeking a Records Coordinator for its Plymouth location. Key Responsibilities include: Executes US and International regulatory strategies for product submissions, identifying needs for bench, animal, and clinical testing with direction of senior staff. With of senior department members, participates on Product Development teams, providing input on regulatory, strategy, timeliness, and direction. Prepares US and International submission, under the guidance of senior staff, and work with government agencies and/or distributors to obtain product approval/clearance. Serves as informational resource for all departments, assisting in keeping company informed of US and International regulatory requirements. Ensures relevant International ISO and FDA Export requirements are met, as required and ensures accuracy of submission information. Initiates FDA export approval requires and product release authorizations. Reviews ECO's and assess effect of product changes on US and International regulatory strategy and submissions per standard procedures. Assists wih recall/retrieval documentation and other activities. Develops and maintain regulatory status documents and submission procedures. Assists senior staff with implementation of new methodologies associated with product quality and quality systems. Required Skills: Bachelor's degree in a related field Minimum 1 year of US and International medical device industry experience preparing documents for regulatory Experience with FDA Quality Systems and ISO requirements and documents Preferred Skills: Strong communication and technical writing skills. Ability to work in a team environment. Highly organized and able to work on and track mulitple projects simultaneously. Skill in working with computers and experience with spreadsheet and word processing software. Ability to research current international requirements. Ability to address concurrent demands from multiple sources. 6 month contract position, with the possibility to go permanent. Please apply online to minneapolis mn minnesota
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