Javier Castillo Álvarez

Javier Castillo Álvarez has a wealth of experience in the Quality and Regulatory Affairs field. In 2008, they held a Chemical Researcher Fellowship with Eusko Jaurlaritza - Gobierno Vasco. In 2010, they held a Laboratory Technician Fellowship at Eli Lilly & Co. Research & Development Laboratory. In 2011, they were a Quality & Process Engineer at GN ReSound, where they reviewed, updated, managed and audited the QMS (ISO 9001, 13485, MDD). Javier was also responsible for verifying the fulfilment of applicable regulatory requirements, maintaining the Vigilance System and Post Production Surveillance Process, and managing quality issues, complaint resolution and Corrective and Preventive Actions. In 2016, they were Quality & Regulatory Affairs Manager at both MedLumics, S.L. and DermaLumics. Javier was responsible for defining, managing and maintaining the ISO 9001 and ISO 13485 Quality Management System under the scope of MDD 93/42/EEC and FDA CFR 820, and ensuring the fulfilment of applicable Regulatory requirements globally. In 2018, they held three roles at Align Technology, including Sr. Manager, Global QMS, Sr. Quality Manager Treat EMEA, and Quality Assurance Manager. In this role, they were responsible for ensuring a compliant FDA, and ISO 13485 quality system for Align Technology, including management of compliance, internal audits, and quality engineering related activities. In 2020, they became an Expert at BioExpert Network. Lastly, in 2022, they will become the Head of Quality and Regulatory at INBRAIN Neuroelectronics, where they will lead the Quality and Regulatory Affairs team, establish quality and regulatory strategies, build and develop the quality and regulatory teams, and promote quality awareness throughout the organization.

Javier Castillo Álvarez has a diverse educational background. Javier completed a Citius internship at the Universidad Autónoma de Madrid from 2010 to 2011, with a focus on Multi-/Interdisciplinary Studies, General. In 2014 and 2015, they attended the Asociación Española para la Calidad and earned a Risk Management degree in Business Administration and Management. From 2002 to 2009, they earned a Degree in Chemistry and a Licenciatura in Química from the Universidad del País Vasco/Euskal Herriko Unibertsitatea.