Identifies regulatory classification and designation per relevant regulations, guidance documents, international standards, or consensus standards Assists in preparation of premarket FDA, and international regulatory submissions, with technical review of data and reports Assists in communication with regulatory agencies via pre-submissions and responses to premarket submission requests Development, revision and/or ongoing operation of Quality System procedures and processes Internal and supplier audit planning and execution Serve as a company representative during external audits by Regulatory and Third Party Auditors Design Control documentation assistance Validation and Testing Protocol support Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements