Iñigo Ruiz López

Quality Assurance & Regulatory Affairs Manager, PRRC at ABLE Human Motion

Iñigo Ruiz López has a diverse work experience in various roles and industries.

From 2021 to the present, they serve as the Quality Assurance & Regulatory Affairs Manager at ABLE Human Motion. Iñigo is responsible for ensuring regulatory compliance and CE certification for medical devices. Iñigo has successfully managed clinical investigations, coordinated the development of clinical documentation, and maintained the Quality Management System.

Prior to their current role, from 2021 to 2022, Iñigo worked as a Quality Assurance & Regulatory Affairs Specialist at ABLE Human Motion. Iñigo assisted with technical documentation preparation, led risk management and usability engineering activities, and drove documentation management within the Quality Management System.

In 2020, they worked as a Global Regulatory Documentation Assistant at Firmenich, where they produced documents, performed compliance checks, and collaborated with the Quality Assurance and Commercial teams to deliver documentation to clients.

In 2019, Iñigo gained research experience as a Postgraduate Researcher at Imperial College London. Iñigo completed a Masters in research on structural molecular biology, with a focus on cryogenic electron microscopy data processing and analysis.

In 2018, as an Undergraduate Researcher at Parc Científic de Barcelona, they investigated the molecular mechanisms of splicing in yeast. Iñigo performed various laboratory techniques and worked on their own project while assisting others in the lab.

In 2017, they worked as an Undergraduate Researcher at Universitat Autònoma de Barcelona in the Department of Cell Biology, Physiology, and Immunology. Iñigo conducted RNA and DNA extractions and performed qPCR analysis.

Overall, Iñigo Ruiz López has a strong background in quality assurance, regulatory affairs, research, and laboratory techniques across multiple industries.

Iñigo Ruiz López's education history is as follows:

From 2015 to 2019, Iñigo attended the Universitat Autònoma de Barcelona, where they pursued a Bachelor's degree in Biotechnology, focusing on Biotecnología.

In 2017 and 2018, Iñigo participated in the Erasmus+ program at the University of Dundee, working towards a Bachelor's degree in Biological and Biomedical Sciences.

In 2019, Iñigo enrolled at Imperial College London and completed a Master's degree (MRes) in Structural Molecular Biology.

In 2020, Iñigo moved to the Universitat de Barcelona to pursue a degree in Regulatory Affairs: Authorisation of Medicines, Medical Devices, and Non-Medicinal Products, specializing in Pharmaceutics and Drug Design. Iñigo completed this program in 2021.

In addition to their formal education, Iñigo has obtained various certifications. In 2015, they earned the Cambridge Certificate of Advanced English (CAE) - CEFR C1 from the University of Cambridge. Iñigo also obtained the Diplôme d'études en langue française (DELF) B2 from Alliance Française Paris Île-de-France in the same year.

More recently, Iñigo acquired the following certifications: CIMTI 2121 - Medical Devices Regulatory Affairs MDR 2017/745 - IVDR 2017/746 from Tecno-med Ingenieros in 2022, Interpretation and Application of ICH E6(R2) (Good Clinical Practice, GCP) from the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) in 2021, and Risk Management according to MDR/IVDR and EN ISO 14971 from Tecno-med Ingenieros in 2021. Additionally, they obtained certifications in Decision-Making in High-Stress Situations and Managing Team Conflict from LinkedIn in 2020.

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Previous companies

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Timeline

  • Quality Assurance & Regulatory Affairs Manager, PRRC

    April, 2022 - present

  • QA/RA Specialist

    February, 2021

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