Elias Ali Azawee

Background

About Elias Ali Azawee

I’m a chemical engineer working at the intersection of quality, product development, and patient safety. With a foundation in analytical chemistry and pharmaceutical quality control, I transitioned into medical device R&D, where I now specialize in design control, risk management (ISO 14971), and regulatory compliance throughout the product lifecycle. My career started at Rechon Life Science, where I led QC projects involving method development, validation, and transfer for new clients. I gained hands-on experience with HPLC, GC, stability studies, and GMP compliance, while also supporting process validation and certifying analysts on analytical instruments. Today, in medtech, I ensure that medical devices are developed in line with ISO 13485, FDA design control requirements, and ISO 14971. I manage design history files, risk management files, usability documentation, and help teams navigate complex regulatory expectations. My goal is to embed risk-based thinking into every stage of product development—from concept to launch.