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Senior Regulatory Affairs Specialist
Ref No.: 18-13081
Location: irvine, California
Start Date: 10/04/2018
1.1. Senior Program Lead/Specialist, Regulatory Affairs support activities
1.2. Under direct and indirect supervision of Buyer leadership, the Role Responsibilities and Activities such as but not limited to
Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
Instill and drive a regulatory culture. Establish and support policies and standards for the measurement of new products.
Develop IDE/510K/ and PMA submissions for class II and III medical devices.
Conduct submission negotiations with the FDA as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
Maintain proficiency on regulatory requirements and develop and maintain rapport with FDA reviewers, project team members.
Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or Pharmaceutical affiliates.
Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.