Rania De Leon
About Rania De Leon
Rania deLeon is a Regulatory Affairs Manager and biomedical engineer with extensive experience in the medical device industry, specializing in cardiac electrophysiology.
Rania deLeon Regulatory Affairs Manager
Rania deLeon serves as a Regulatory Affairs Manager, leveraging her seven years of experience in the medical device industry. Her expertise spans quality assurance and regulatory affairs, with a specialized focus on cardiac electrophysiology. In this role, she manages regulatory processes to ensure compliance with international medical device regulations and standards.
Rania deLeon Biomedical Engineer Background
Rania deLeon is a trained biomedical engineer with a robust background in developing and managing medical devices. Her engineering skills are complemented by practical experience in quality assurance and regulatory affairs within the cardiac electrophysiology sector. This combination allows her to effectively navigate the complex regulatory landscape of the medical device industry.
Medical Device Approvals by Rania deLeon
Throughout her career, Rania deLeon has successfully achieved medical device approvals from several major regulatory bodies including the FDA, Health Canada, the European Union, and Australia. Her efforts have enabled the deployment of medical devices that are currently assisting thousands of cardiologists worldwide in their practice.
Electronic Quality Management Systems by Rania deLeon
Rania deLeon has notable experience in building electronic quality management systems (eQMS) from the ground up. These systems are crucial for ensuring that medical devices comply with required standards and regulations. Her work in this area demonstrates her ability to integrate regulatory requirements into efficient and effective quality management practices.