Wednesday, 4 July 2012

Regulatory Affairs Associate

Details: Bard Peripheral Vascular, located in Tempe, AZ – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives.From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists.Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.Essential Job Functions:1. Supports senior Regulatory personnel prepare new product marketing submission for the FDA (510k, PMA).2. Maintains all Regulatory Affairs documentation.3. Assists as a Regulatory representative on New Product Development teams.4. Supports all international Regulatory requests.5. Sends out notifications of change to the Notified Body as required.6. Supports divisional and corporate litigation requests as needed.7. Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate  requirements.8. Performs on special projects as required.

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