• Assist in reviewing customer complaints and determining MDR/MIR reportability based on regulatory guidelines. • Help prepare and submit initial, supplemental, and final adverse event reports within required regulatory timelines. • Support team efforts to ensure all adverse event submissions meet global regulatory deadlines. • Work with regulatory representatives, customers, and field teams to gather additional information for complaint investigations and regulatory requests. • Review complaint records prior to closure to help ensure accuracy and compliance with relevant regulations and standards. • Participate in investigations of nonconformities and contribute to corrective or preventive action activities. • Provide support during internal and external audits, including organizing documentation and assisting with data preparation. • Contribute to process improvements, maintain familiarity with applicable regulations, and support training or systems use (e.g., TrackWise) as needed.