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.Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan around product development/line extension goals.2. Prepares U.S. FDA submissions (e.g., 510(k), IDE) as required and per applicable SOPs.3. Prepares and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.4. Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.5. Assists Bard Corporate in updating establishment registrations and device listings as required.6. Ensures adequate documentation of Bard Peripheral Vascular's compliance to FDA, European and international regulations and standards. Ensures continuous update and maintenance of the Regulatory Affairs files.7. Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Peripheral Vascular's notified body.
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