Irina Lopes

Experience

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  Clynx Health

  Jan 2022 - Jan 2024

  Clynx helps healthcare providers optimize their Physiotherapy experiences and expand their responsiveness, through a digital gamified solution that can be used in the healthcare unit and at home.My responsibilities:• Implementation of the Quality Management System (ISO 9001/ISO 13485).• Production of Clinical Studies for Clinical Evaluation (MDR 2017/745, MDCGs) on Software Technical Performance Validation.• Scientific Research.• Representation of Clynx Health in the Net Zero Health Systems Acceleration Program. Daha az göster

  • Medical & Regulatory Affairs Representative

    Jan 2023 - Jan 2024

  • Regulatory Affairs Intern

    Jan 2022 - Jan 2023
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  Glooma

  Jan 2024 - Jan 2025

  Engineering & Compliance Specialist

  Glooma is a start-up revolutionizing early breast cancer detection. Our device, SenseGlove, is designed to detect and monitor breast tissue changes, aiming to improve early diagnosis and deliver personalized care.My responsabilities:• Serve as a key liaison between the Product and Regulatory Affairs teams, ensuring full compliance with medical device regulations.• Develop and manage comprehensive technical documentation to support CE Marking and FDA approval for medical devices.• Design and oversee usability and performance verification clinical studies, ensuring adherence to stringent regulatory requirements in the EU and USA. Daha az göster

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  European Commission

  Jan 2024 - Jan 2024

  Scientific Trainee

  Safety and Performance of Medical Devices and In-Vitro Diagnostics @ Health & Food - Technologies for Health Unit, Joint Research CenterIn the European Commission’s Joint Research Centre, we carry out research in various fields to provide independent advice to EU policymakers and put science at the heart of European policies.My responsibilities:• Scientific/technical support for medical device regulations (MDR & IVDR) implementation, including presence in MDCG meetings.• Method development for breast implant characterization, including biological assays to assess inflammatory response, surface characterization, and particle analysis. Contributed to the review process of ISO 14607, enhancing safety testing standards for breast implants.• Contribution to the establishment of EU Reference Laboratories for high-risk in vitro diagnostic medical devices.• Development of a comprehensive report on medical countermeasures during the COVID-19 pandemic, analysing the pros and cons of preventive vaccines and therapies, and providing recommendations for improved preparedness against future health threats.• Collaboration within the European Commission (specifically DG-SANTE: Health & Food Safety). Daha az göster

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  European Union Drugs Agency (EUDA)

  Mar 2025 - now

  Trainee

  Trainee at Substance Use, Harms & Response Unit - Drugs Use, Harms & Addictive Behaviours SectorThe European Union Drugs Agency (EUDA) is the EU’s leading authority on illicit drugs, providing independent scientific evidence and analysis to support policies that protect citizens from drug-related harms.My responsabilities:• Support to the implementation of the Health & Security Threat Assessment System, enhancing EU preparedness for emerging drug-related threats.• Analysis data from EU Member States on new psychoactive substances to support evidence-based policymaking.• Data analysis on the ESCAPE project on analysis of drugs in used syringes.• Data analysis on drug-related infectious diseases (HIV, HCV, and HBV) among people who use drugs, contributing to public health reporting and policy recommendations. Daha az göster