Lyra M.

Lyra Mae B. is a seasoned Regulatory Officer in the medical device sector, adept at ensuring compliance with ISO standards and EU regulations. With a solid trajectory in managing quality management systems, Lyra excels in leading internal audits, conducting root-cause analysis, and coordinating with external certification bodies. Her expertise lies in documentation management and maintaining regulatory compliance, particularly for ISO 13485:2016 and MDSAP guidelines. Previously serving as a Document Control Clerk, she honed skills in document accuracy and compliance, establishing retention schedules and optimizing document flow. Currently, she fosters operational efficiency and a culture of quality through company-wide training initiatives and risk assessment management, particularly within the framework of Risk Management to Medical Devices (ISO 14971). Lyra holds a Bachelor’s degree in Business Administration with a major in Financial Management from Palawan State University, graduating with distinction.