andrés gola isasi

I am a professional specialized in regulatory compliance and quality within the life sciences industry, with more than 15 years of international experience across the pharmaceutical, biotechnology, and medical device sectors. Throughout my career, I have worked for multinational companies such as Johnson & Johnson, BD, and Zimmer Biomet, participating in projects related to process validation, technology transfer, quality assurance, supplier management, and regulatory compliance for Class III medical devices and combination products. I currently work at PharmaBioServ, where I support companies through consulting, project management, and business development activities focused on quality, regulatory affairs, and operational excellence. In addition to my industry experience, I combine my professional work with university teaching and research in biomedical engineering. I am an Adjunct Professor at the University of Deusto, where I teach courses related to healthcare regulations, pharmacology, and biomedical engineering. I have also participated in research projects related to medical image processing, artificial intelligence applied to healthcare, and algorithm-based diagnostic systems, collaborating with institutions such as the Bascom Palmer Eye Institute and the eVIDA Group. In addition, I hold international certifications including PMP, RAC, and Six Sigma Black Belt, and I contribute as a specialized author of regulatory affairs content for the life sciences industry.

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