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I am a Senior Medical Writer with over 7 years of experience specializing in regulatory and clinical documentation for MedTech and SaMD startups. My expertise spans women's health, translational research, and AI-driven scientific communication. I hold a PhD in Biomedical Sciences and am fluent in English and Spanish, with a solid understanding of ICH-GCP, ISO 14155, and EU MDR. I thrive in dynamic environments, managing multiple projects with cross-functional teams under tight deadlines. Currently, I work as a Regulatory Scientific Writer and Consultant, leveraging AI and digital tools to enhance medical content and help startups navigate FDA, EFSA, and EU regulatory frameworks. My experience extends to scientific training workshop development, grant contribution, risk assessment leadership, and clinical nutrition support, making me a versatile communicator and collaborator eager to contribute to advancing healthcare innovations.…I am a Senior Medical Writer with over 7 years of experience specializing in regulatory and clinical documentation for MedTech and SaMD startups. My expertise spans women's health, translational research, and AI-driven scientific communication. I hold a PhD in Biomedical Sciences and am fluent in English and Spanish, with a solid understanding of ICH-GCP, ISO 14155, and EU MDR. I thrive in dynamic environments, managing multiple projects with cross-functional teams under tight deadlines. Currently, I work as a Regulatory Scientific Writer and Consultant, leveraging AI and digital tools to enhance medical content and help startups navigate FDA, EFSA, and EU regulatory frameworks. My experience extends to scientific training workshop development, grant contribution, risk assessment leadership, and clinical nutrition support, making me a versatile communicator and collaborator eager to contribute to advancing healthcare innovations.

Fabio Alejandro Aguilar Mora, PhD

Writer, AI Prompt Engineer, Project Manager, +1

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I am a Senior Medical Writer with over 7 years of experience specializing in regulatory and clinical documentation for MedTech and SaMD startups. My expertise spans women's health, translational research, and AI-driven scientific communication. I hold a PhD in Biomedical Sciences and am fluent in English and Spanish, with a solid understanding of ICH-GCP, ISO 14155, and EU MDR. I thrive in dynamic environments, managing multiple projects with cross-functional teams under tight deadlines. Currently, I work as a Regulatory Scientific Writer and Consultant, leveraging AI and digital tools to enhance medical content and help startups navigate FDA, EFSA, and EU regulatory frameworks. My experience extends to scientific training workshop development, grant contribution, risk assessment leadership, and clinical nutrition support, making me a versatile communicator and collaborator eager to contribute to advancing healthcare innovations.…I am a Senior Medical Writer with over 7 years of experience specializing in regulatory and clinical documentation for MedTech and SaMD startups. My expertise spans women's health, translational research, and AI-driven scientific communication. I hold a PhD in Biomedical Sciences and am fluent in English and Spanish, with a solid understanding of ICH-GCP, ISO 14155, and EU MDR. I thrive in dynamic environments, managing multiple projects with cross-functional teams under tight deadlines. Currently, I work as a Regulatory Scientific Writer and Consultant, leveraging AI and digital tools to enhance medical content and help startups navigate FDA, EFSA, and EU regulatory frameworks. My experience extends to scientific training workshop development, grant contribution, risk assessment leadership, and clinical nutrition support, making me a versatile communicator and collaborator eager to contribute to advancing healthcare innovations.

Available to hire

I am a Senior Medical Writer with over 7 years of experience specializing in regulatory and clinical documentation for MedTech and SaMD startups. My expertise spans women’s health, translational research, and AI-driven scientific communication. I hold a PhD in Biomedical Sciences and am fluent in English and Spanish, with a solid understanding of ICH-GCP, ISO 14155, and EU MDR. I thrive in dynamic environments, managing multiple projects with cross-functional teams under tight deadlines.

Currently, I work as a Regulatory Scientific Writer and Consultant, leveraging AI and digital tools to enhance medical content and help startups navigate FDA, EFSA, and EU regulatory frameworks. My experience extends to scientific training workshop development, grant contribution, risk assessment leadership, and clinical nutrition support, making me a versatile communicator and collaborator eager to contribute to advancing healthcare innovations.

Skills

Experience Level

Expert

Expert

Expert

Intermediate

Language

English

Fluent

Spanish; Castilian

Fluent

Dutch

Intermediate

Work Experience

Regulatory Scientific Writer & Scientific Consultant at Boostology

January 1, 2024 - Present

Provide strategic regulatory advice and support funding documentation for MedTech startups, primarily focused on FDA and EFSA food market regulations. Review AI model-generated scientific content for accuracy and consistency. Develop AI training datasets in toxicology and pharmacology. Design and deliver educational workshops on maternal health and microbiome science. Create learning materials, host health education events, and incorporate stakeholder feedback to improve participant experiences.

Scientific Writer & Risk Assessment Lead at The NU (SaMD)

January 1, 2024 - August 27, 2025

Authored clinical study reports, protocols, and Investigator’s Brochure updates for AI-assisted risk modeling and personalized nutrition platforms. Translated GWAS risk factors into compliant materials for consumers and clinicians. Led editorial quality assurance ensuring compliance with academic and regulatory standards. Designed digital systems in Notion for compliance and workflow management. Coordinated cross-functional teams and developed AI-based medical content and prompt engineering strategies.

Regulatory Scientific Writer & Grant Contributor at FFUND (collaborating with clients including Bayer, Johnson & Johnson, and Erasmus MC)

December 31, 2022 - August 27, 2025

Authored clinical study reports, protocols, and IB updates complying with ISO 14155, ICH-GCP, and EU MDR for MedTech startups. Contributed to CTD/IMPD modules for CE marking and regulatory submissions. Coordinated cross-functional teams ensuring timely delivery of regulatory submissions via EU portals. Managed timelines and QA using Notion. Provided strategic advice on regulatory positioning and mentored junior writers.

Clinical Nutrition & QA Support at ISSTE Public Hospital

January 1, 2018 - August 27, 2025

Delivered patient education and quality assurance documentation for dietary treatment plans. Conducted clinical studies on toxicological biomarkers. Communicated research findings with cultural sensitivity to patients and medical staff.