1. Implement regulatory and quality strategies to ensure that medical products comply with FDA and international regulations governing product quality and safety. 2. Prepare, review, and maintain FDA regulatory submissions and compliance documentation for medical devices and related healthcare products, including premarket notifications and related filings. 3. Develop, implement, and audit quality management systems to verify alignment with FDA requirements, industry standards, and company policies. 4. Apply practical knowledge of FDA and ISO quality regulations to support compliant product development and manufacturing activities. 5. Collaborate with cross-functional teams to integrate regulatory and quality requirements into product design, development, and commercialization. 6. Monitor and interpret changes in medical product regulations and provide corresponding guidance and training to ensure ongoing compliance and market readiness. 7. Maintain regulatory databases and ensure accurate records of FDA submissions, correspondence, and compliance documentation.

Regulatory Affairs and Compliance, Quality Management, Biomedical Engineering, or a closely related field with emphasis on medical devices