Regulatory Affairs II (Reg II) - Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence including clinical data Ensure compliance with regulatory agency regulations and interpretations Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines Prepare responses to regulatory agencies questions and other correspondence to resolve post-submission queries... more details
Regulatory Affairs II (Reg II) – Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence including clinical data Ensure compliance with regulatory agency regulations and interpretations Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines Prepare responses to regulatory agencies questions and other correspondence to resolve post-submission queries ensuring timely approvals Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed Provide solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers Guide conformance with applicable regulations in product development, support of claims and label content Define data and information needed for regulatory approvals Collaborate in the development and approval of labeling, after evaluating conformance to regulations Provide Regulatory Affairs support during internal and external audits Plans schedules for regulatory deliverables on a project and monitors project through completion Assists in the development of best practices for Regulatory Affairs processes and systems Represents Regulatory Affairs and provide regulatory advice on cross-functional project teams Partners with other functions to define and obtain data to assist with regulatory submissions Responsible for communicating business related issues or opportunities to next management level Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed
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