Regulatory Affairs Specialist 3 (Addison, TX)

Regulatory Affairs Specialist 3 (Addison, TX) The Regulatory Affairs Specialist 3 develops and executes regulatory strategies, integrating regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop, and maintain materials needed for regulatory compliance. Uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower-level specialists in regulatory activities. Responsibilities Ensure all processes for essential functions are documented in procedures. Perform internal departmental audits and support audits by third parties such as BSI, FDA, and others. Initiate and maintain required establishment listings (e.g., FDA, EU), including renewal or changes. Develop company regulatory strategies and prioritize activities. Determine the best strategy to register new products in specific global markets. Determine appropriate product testing to support registration activities. Ensure content accuracy and regulatory compliance for submissions to agencies (e.g., 510(k), PMA, MDR Technical Files/Design Dossiers, global registration applications). Provide feedback and approval of compliant labeling (e.g., IFUs, marketing materials, package labels). Manage and lead responses to regulatory agencies for submission deficiencies. Maintain accurate international product registration, including renewals, changes, and certificates for foreign governments. Provide guidance to other Regulatory Specialists as needed. Qualifications 5+ years of regulatory experience in the medical device industry (equivalent industry or educational experience may be considered). Knowledge of applicable FDA, ISO, MDR requirements, consensus standards, and guidance documents. Ability to work independently with FDA, Notified Bodies, EU Authorized Representatives, and other global agencies. Ability to manage multiple projects simultaneously. Proven teamwork skills and strategic thinking. Ability to support regulatory activities and mentor/train others. Excellent written and verbal communication skills. Master of Science in Regulatory Affairs preferred. #J-18808-Ljbffr