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Job #03121

About our client Our client is a sports medicine product distributor that focuses on innovative products that are changing the way companies view the sports medicine industry. Their long line of products include support wraps and braces for joint injuries, as well as mouth guards and other sports accessories. Our client values teamwork and creative thinking and rewards employees with a competitive compensation package. This is a challenging opportunity for the right candidate. Position Location International Regulatory Affairs and Quality Specialist Prairie du Sac, Wisconsin Salary Highly competitive package, commensurate with experience Responsibilities 1) Organize and lead the training for all international employees in quality system procedures and regulatory guidelines 2) Develop and maintain internal quality system processes for international locations 3) Provide support of international customers and distributors to resolve product inquiries 4) Maintain Quality Assurance record retention for international distributors 5) Analyze facts or circumstances surrounding individual problems to determine what action should be taken within the limits of standard practices 6) Investigate and determine cause of faulty work as well as consult and advise production supervisors as to corrective measures 7) Oversee registration of products in a foreign country 8) Supply and maintain certificates of exportability for foreign government from the US FDA 9) Provide authenticated documents (as necessary) 10) Assess international regulations and provide an interpretation of company impact 11) Provide understanding of compliance international regulations and requirements for countries where new products are marketed 12) Provide back-up support for Quality Management personnel 13) Understand and comply with the company’s quality management system and current regulatory requirements 14) Oversee product quality issues as well as regulatory affairs as they pertain to products sold internationally by the company 15) Ensure that the company products comply with all regulations in all countries where products are marketed and facilitate the registration of product in various countries 16) Perform other duties as assigned Requirements 1) BS from an accredited university in a scientific (or equivalent) field or in Regulatory Affairs 2) Minimum 2 – 5 years of experience in a quality/regulatory position (preferably as a Manager) 3) Knowledge of quality system guidelines 4) Knowledge of aspects of regulatory affairs pertaining to human drugs, food, cosmetics and medical devices (regional and national level) 5) Good computer skills in MS office and the Internet (SAP preferred) 6) Ability to multi-task and make firm decisions 7) Ability to communicate effectively, make presentations and write concise reports for all levels of employees