Experience

INGECAL

• Spain
• Business Consulting and Services
• 1 - 100 Employee

• Regulatory Affairs and Quality Assurance Consultant - Medical Devices

  • Feb 2020 - Present

  - Transition to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR); - Obtention of CE marking and QMS Certification (ISO 13485); - Technical files for medical devices and in vitro diagnostic devices; - Risk Management in compliance with ISO 14971; - Clinical and Performance Evaluations; - Post-market surveillance follow-up (PMS); - Technical files for personal protective equipment (PPE). - Transition to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR); - Obtention of CE marking and QMS Certification (ISO 13485); - Technical files for medical devices and in vitro diagnostic devices; - Risk Management in compliance with ISO 14971; - Clinical and Performance Evaluations; - Post-market surveillance follow-up (PMS); - Technical files for personal protective equipment (PPE).



Eurofarma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Mar 2018 - Jul 2019

  - Responsible for maintaining a portfolio with 60 products (generic, brand name, specific, biological and veterinary drugs);- Regulatory maintenance activities of product lifecycle: renewals, line extension and authorizations;- Elaboration, review and submission of post-approval changes related to the finished product or API, such as changes in the manufacturer process or supplier, specifications, packaging material, shelf-life or storage conditions and product formulation;- Impact assessment of new regulations. Show less

• • Feb 2017 - Mar 2018

  - Assisting the preparation of renewals and minor variations for postapproval changes;- Evaluation of packaging and promotional material;- Support the technical and regulatory evaluation of analytical reports, methods, specifications and stability study.



Université Grenoble Alpes

• France
• Higher Education
• 700 & Above Employee

• Research Internship

  • Apr 2016 - Jun 2016

  Extracurricular research internship in the development of anti-inflammatory ophthalmic formulations at the Department of Molecular Medicinal Chemistry of Faculty of Pharmacy - Grenoble Alpes University. Collaboration in the project "Medicinal chemistry of antischistosomal drugs: Praziquantel and oxamniquine". Extracurricular research internship in the development of anti-inflammatory ophthalmic formulations at the Department of Molecular Medicinal Chemistry of Faculty of Pharmacy - Grenoble Alpes University. Collaboration in the project "Medicinal chemistry of antischistosomal drugs: Praziquantel and oxamniquine".



Alcon

• Switzerland
• Medical Equipment Manufacturing
• 700 & Above Employee

• • Oct 2014 - Jul 2015

  - Management and investigation of products' complaints, deviations and nonconformities of the production site located in São Paulo;- Instructor of the course provided by Quality Assurance to certify other coworkers as investigators of their respective department;- Participation in a project for implementation of TrackWise as a new system of non-conformities management. Main activities: elaborate the standard operating procedures, define users' access and create a plan for coworkers training. Show less

• • May 2014 - Oct 2014

  - Supporting the daily activities of management and investigation of products' complaints, deviations and nonconformities;- Development of new productive documentation of filling and packaging.



USP - Universidade de São Paulo

• Brazil
• Higher Education
• 700 & Above Employee

• Research Internship

  • Sep 2011 - Dec 2013

  Projects: • Study of the localization of PfSR10, a serpentine receptor candidate, in Plasmodium falciparum. Project funded by the National Council for Scientific and Technological Development (CNPq); • Determination of intracellular concentration of Ca2 + ions involved in the cellular signaling of Plasmodium falciparum from calcium indicators containing GFP. Projects: • Study of the localization of PfSR10, a serpentine receptor candidate, in Plasmodium falciparum. Project funded by the National Council for Scientific and Technological Development (CNPq); • Determination of intracellular concentration of Ca2 + ions involved in the cellular signaling of Plasmodium falciparum from calcium indicators containing GFP.