Principal Regulatory Affairs Specialist - (US-UT-South Jordan - 84095)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Teams with Corporate and International Regulatory staffs to provide support for new products and changes to existing products. Works with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepares FDA submissions, Technical Files, Canadian Applications and International Dossiers for new products and product changes. Prepares documentation for Clinical Studies and coordinate and maintain study communications. Reviews significant product and clinical study submissions with management and negotiate submission issues with agency personnel. Provides support to currently-marketed products as necessary by reviewing labeling, promotional materials, and product and documentation changes per policy and procedure. Interact directly with the FDA and/or indirectly with international regulatory agencies on most products/projects at reviewer level; all significant issues will be reviewed with management. Supports regulatory compliance activities, including manufacturing site registration, GMP, Notified Body audit, post market vigilance reporting, product recalls, etc., as needed. Maintains proficiency in worldwide regulatory requirements; establishes and maintains positive relationships with agency personnel. Provides business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to management. Provides feedback and on-going support to product development teams for regulatory issues and questions. Ensures personal understanding of all quality policy/system items that are applicable. Performs other related duties and tasks, as required.

Requirements :Bachelor's Degree in the biological, physical, engineering or material science disciplines. Seven years of regulatory experience, with three of those years of pre and post market clinical trials. Must have experience working with principal investigators, research coordinators, IRBs and Ethics committees. Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC) ISO 13485 Quality System Standard and Canadian Medical Device Regulation.

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