Associate II, Regulatory Affairs

Job description

Position Summary Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables. With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management. Essential Duties & Responsibilities: - Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations. - Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines. - With oversight, understand and respond to regulatory agency correspondence. - Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review. - Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. - Represent...