Gustavo Santos

Regulatory Affairs and Quality Engineer with eight years of experience across Electrical and Electronic Engineering, combining hands-on technical design expertise with regulatory compliance and quality management experience. Supported by a Master's degree in Project Management, I have worked across both engineering development and regulated product environments, giving me a strong understanding of the complete product lifecycle from concept and design through to manufacturing, compliance, and product release. Experienced in supporting compliance activities, technical documentation, quality management systems, change management, and continuous improvement within fast-paced electronic manufacturing environments.

Able to work effectively across multidisciplinary teams while balancing regulatory requirements with practical engineering and commercial objectives. I am particularly motivated by roles that combine innovation, technology, and compliance, where I can contribute both technically and strategically to building efficient, scalable, and high-quality regulatory and operational systems.

R&D Quality Manager & Regulatory - Eppendorf Cryotech

(2018-08)

Responsible for regulatory compliance and quality activities across the full product lifecycle for laboratory, machinery, and electronic products, supporting R&D, Quality, Production, and Lifecycle Management functions. Previous experience as an Electronic Design Engineer provides strong technical understanding across product development, manufacturing, and regulatory compliance.

• Led regulatory compliance activities across the full product lifecycle for laboratory, machinery, and electronic products
• Coordinated external testing, certification, and compliance activities including Machinery Directive, LVD, UL, EMC, FCC, and material compliance
• Supported quality management systems, risk management, DFMEA, and lifecycle compliance activities
• Managed technical documentation, product labelling, regulatory records, and international standards compliance
• Collaborated with R&D, Quality, Production, and Project Management teams to ensure compliant product development and successful production transfer
• Supported verification, validation, traceability, and continuous improvement initiatives while reducing regulatory complexity and unnecessary testing effort
• Provided regulatory impact assessments and compliance guidance for engineering changes and product modifications
• Translated IEC and regulatory standards into practical engineering and design requirements
• Coordinated cross-functional activities to support manufacturing quality, product conformity, and post-market compliance
• Supported risk-based compliance strategies, design mitigation activities, and efficient validation planning

Facilities management - Serpentine Gallery

(2012-01 - 2018-01)

Managed facility operations, maintenance coordination, contractor support, and compliance activities while ensuring efficient day-to-day operations, health & safety compliance, and continuous service improvement.

• Ensure all engineering reports are completed.
• Manage maintenance strategies for various essential systems and infrastructure.

Master's - Medical Devices Regulatory Affairs - Atlantic Technological University & University of Galway (2026)

Master's - Project Management - Anglia Ruskin (2021 - 2024)

Bachelor's - Electrical and Electronic Engineering - University of West London (2015 - 2018)