Experience

INBRAIN Neuroelectronics

• Spain
• Technology, Information and Internet
• 1 - 100 Employee

• Head of Quality and Regulatory

  • Jul 2022 - Present

  Leading the Quality and Regulatory Affairs team, establishing quality and regulatory strategies. Build and develop the quality and regulatory teams, supporting the development, implementation, and continuous improvement of the quality management system and ensuring the integrity of the system is maintained. Promoting quality awareness throughout the organization, setting-up an ISO 13485:2016 compliant Quality Management System to achievecertification. Chairing Management Reviews and advising management, preparing and coordinating activities during internal and external audits, planning and executing supplier audits. Leading discussions with regulatory bodies both in Europe and US, driving INBRAIN’s regulatory strategy in alignment with clinical programs both in Europe and US in parallel, supporting clinical trial submissions and release of investigational devices.



BioExpert Network

• Spain
• Biotechnology Research
• 1 - 100 Employee

• Expert

  • Jan 2020 - Present

  Regulatory Affairs and Quality Assurance expert for Medical Device sector, providing professional assessment to companies in fundraising phase on market access through CE mark and PMA/510k. Regulatory Affairs and Quality Assurance expert for Medical Device sector, providing professional assessment to companies in fundraising phase on market access through CE mark and PMA/510k.



Align Technology

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Sr. Manager, Global QMS

  • Jan 2022 - Jul 2022

  Global Quality Management Systems responsible at Align Technology.

• Sr. Quality Manager Treat EMEA

  • Jan 2021 - Jan 2022

  Senior Manager para el equipo de QA/RA en Treat Commercial EMEA

• Quality Assurance Manager

  • Apr 2018 - Jan 2021

  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. Provide quality expertise on daily production issues, process improvements, guidance on failure analysis and customer complaint resolution, and interfacing with regulatory agencies.



MedLumics, S.L.

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality & Regulatory Affairs Manager

  • Jan 2016 - Apr 2018

  Define, manage and maintain the ISO 9001 and ISO 13485 Quality Management System under the scope of MDD 93/42/EEC and FDA CFR 820. Responsible for the fullfilment of the applicable Regulatory requirements globally. Responsible for Product Regulatory clearance. Risk Management, CE marking and Regulatory documentation. Responsible for the Clinical Investigation management. Responsible for Internal and external Auditing and Supplier Auditing. KPI's definition, management and maintenance. Surveillance System Management, Corrective and Preventive Actions, Non Conformities and Complaints Management. Internal trainer for Quality and Regulatory Affairs.



DermaLumics

• Spain
• Medical Devices

• Quality & Regulatory Affairs Manager

  • Jan 2016 - Jan 2017

  DDefine, manage and maintain the ISO 9001 and ISO 13485 Quality Management System under the scope of MDD 93/42/EEC and FDA CFR 820. Responsible for the fullfilment of the applicable Regulatory requirements globally. Responsible for Product Regulatory clearance. Risk Management, CE marking and Regulatory documentation. Responsible for Internal and external Auditing and Supplier Auditing. KPI's definition, management and maintenance. Survilliance System Management, Corrective and Preventive Actions, Non Conformities and Complaints Management. Internal trainer for Quality and Regulatory Affairs.



ReSound

• Denmark
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality & Process Engineer

  • Apr 2011 - Jan 2016

  Review, update, manage and audit the QMS (ISO 9001, 13485, MDD). Verify the fulfilment of applicable regulatory requirements Maintain Vigilance System and Post Production Surveillance Process. Train Regional Operations Centre functions in regulatory and quality systems; prepare these functions for internal and external audits (Notified Body) Manage quality issues, complaint resolution and Corrective and Preventive Actions. Salesforce.com application succeed manager. Do 3rd Party Suppliers Receiving Inspection, support WH receiving inspection in the interpretation of product specifications, take final decisions on MRB. Monitoring and reporting key metrics for quality performance. Master Data configuration in Microsoft Dynamics NAV (ERP).



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Laboratory Technician

  • Jan 2010 - Jan 2011

  Fellowship as Laboratory Technician at Eli Lilly & Co. Research & Development Laboratory. Screening, design of experiments, method development and process optimization of farmatheutical product synthesis at Automation Technologies Department. Fellowship as Laboratory Technician at Eli Lilly & Co. Research & Development Laboratory. Screening, design of experiments, method development and process optimization of farmatheutical product synthesis at Automation Technologies Department.



Eusko Jaurlaritza - Gobierno Vasco

• Spain
• Public Policy
• 700 & Above Employee

• Cehmical Researcher fellowship

  • Sep 2008 - Jun 2009

  Synthesis, separation and characterization of organic prodcts at Departamento de Química Orgánica II, Universidad del País Vasco (UPV/EHU). Synthesis, separation and characterization of organic prodcts at Departamento de Química Orgánica II, Universidad del País Vasco (UPV/EHU).