Quality & Regulatory Engineer

·       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