Younes Darhbar

WORK HISTORY

EDUCATION

SKILLS

ABOUT YOUNES DARHBAR

As a Quality and Regulatory compliance Manager with several years of experience in the medical device industry, I have proven my ability to ensure design and manufacturing compliance. My expertise includes design quality, risk management, NC and CAPA, complaint handling, PMS and regulatory affairs. My experience is based on a strong regulatory and standards framework for U.S. and EU requirements, as well as an in-depth knowledge of ISO 13485 and ISO 14971. Over the past years, I have been able to build my skills by participating in or leading a wide range of projects for several global leaders in the medical device industry, for product and process including- Process design and remediation - Product development in the US and EU for Class I and Class II medical devices - NC and CAPA management - Change management - Implementation of regulations, directives and standards - Audits and inspections - Training My career is driven by my passion for medical device technologies and my graduate studies, including medical device engineering and quality & project management. Convinced of the major importance of the effectiveness and safety of medical devices for public health and for the sustainability of companies, my mission is to support medical device manufacturers to transform and improve their quality strategies into tailored tools allowing compliance while supporting business.