İrem Şen Email & Phone Number

I am a dedicated and result and risk oriented Quality Assurance Responsible and a Chemist with a strong background in Quality Assurance, Quality Control and Chemistry. My expertise lies in managing Quality Management Systems, navigating regulatory frameworks such as 2017/745 MDR and 2017/746 IVDR, and overseeing all aspects of quality management and quality control processes. I excel in driving process improvements and have extensive experience in medical devices, certification processes, registration processes, supplier processes and working with international test laboratories and notified bodies.I am well-versed in comprehensive risk management, including the implementation of full Risk Management Framework (RMF) processes, as well as expertise in Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Proficiency in UTS and SAP processes is complemented by my familiarity with FDA procedures, as well as a solid foundation in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Throughout my career, I have successfully prepared technical files, safety data sheets, user manuals, product trees. Also performed laboratory tests and equipment maintenance. I graduated from Hacettepe University, Department of Chemistry with an GPA of 2.93. I am a person who loves research and has an investigative spirit as per my profession.