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Gabriel
Regulatory Affairs Specialist
Contacto
Competencias
Experiencia demostrada en Medical Device Compliance.
Experiencia demostrada en Quality Systems.
Experiencia demostrada en FDA Regulations.
Experiencia demostrada en ISO 13485.
Experiencia demostrada en GMP.
Educación
Idiomas
Resumen
Regulatory Affairs Specialist buscando nuevas oportunidades
Experiencia
Regulatory Affairs Specialist
Managed regulatory activities for medical devices, medical supplies, and pharmaceutical products within regulated environments.. Reviewed and evaluated technical and regulatory documentation for compliance, completeness, accuracy, traceability, and supporting evidence.. Conducted regulatory research and compliance assessments to identify documentation gaps, potential risks, and applicable requirements.. Reviewed product information, labels, certificates, manufacturing documentation, and other technical evidence supporting medical device submissions.. Maintained accurate regulatory records and documentation, ensuring traceability, document completeness, and timely completion of assigned deliverables.. Coordinated technical information with clients and internal stakeholders and communicated regulatory requirements and compliance considerations.. Managed multiple regulatory activities simultaneously while maintaining attention to detail, documentation accuracy, and deadlines.. Supported continuous improvement through organization, standardization, and follow-up of regulatory workflows.
Manufacturing Engineer Intern
Supported medical device manufacturing, quality systems, process validation, and continuous improvement activities in a regulated environment.. Coordinated operations for a rework line, monitoring process performance, production data, and daily operational results.. Supported engineering runs, PPQ, and process validation activities, including data collection, technical evaluation, and documentation of results.. Participated in root cause investigations and CAPA-related activities to identify and address process and quality issues.. Investigated process issues using technical information, production data, and evaluation of process conditions to support corrective actions.. Supported technical evaluations and implementation of engineering changes based on process data and identified improvement opportunities.. Prepared and maintained technical documentation, work instructions, Inventory Masters, Bills of Materials (BOMs), and production records.. Supported operator training and compliance with cleanroom, material handling, manufacturing, and quality procedures.. Monitored production performance metrics and prepared daily reports to support technical and operational decision-making.. Collaborated with Engineering, Quality, Operations, and Production teams to resolve issues and improve process performance.
Laboratory Assistant, Biorefinery Research Laboratory
Performed experimental activities, sample preparation, laboratory testing, data collection, and analysis.. Supported interpretation and documentation of experimental results for research activities.. Applied biochemical and microbiological laboratory techniques while following established procedures and maintaining accurate records.