Carlos Pérez Barrionuevo
@carlosprezbarrionuev
Strategic regulatory leader driving market access for medical devices.
BelgiumWhat I'm looking for
I am a regulatory and R&D compliance leader with deep experience bringing medical devices to market across the EU and US.
At MedTech Europe I led MDR gap analyses, advised Working Groups and policymakers, and translated complex regulatory issues into actionable recommendations to preserve device availability.
In industry I directed design control and regulatory submissions for a Class IIa active device, authored a 510(k), maintained MDR technical documentation and drove commercialization and distributor strategy in Spain and Europe.
I combine engineering skills (CFD, ANSYS, SolidWorks), Python automation, and standards expertise (ISO 13485, ISO 14971, EU MDR, FDA 21 CFR) to streamline conformity assessment and accelerate market access.
Experience
Work history, roles, and key accomplishments
MEManager, Medical Devices
MedTech Europe
Aug 2023 - Oct 2025 (2 years 2 months)
Led MDR gap analyses and advised on conformity assessment and policy, shaping strategies that improved device availability and market continuity across the EU; organised and presented workshops to senior regulators and industry stakeholders.
R&D Compliance Engineer
Vision Vent Innovation
Apr 2021 - Jul 2023 (2 years 3 months)
Directed design control and risk management for a Class IIa active device, authored and submitted a 510(k) to the FDA, maintained full technical documentation for EU MDR, and led market-access and distribution efforts in Spain and Europe.
Freelance Engineer
Independent
Feb 2020 - Mar 2021 (1 year 1 month)
Led design validation projects delivering CFD-integrated Python algorithms to accelerate R&D iterations and provided technical blueprints and project management for external clients.
Simulation Engineer
OnRenewables, S.L.
Nov 2017 - Aug 2019 (1 year 9 months)
Provided advanced FEA and CFD simulation services using ANSYS Fluent and SolidWorks to support 3D CAD design for photovoltaic structures, improving structural and aerodynamic performance.
Education
Degrees, certifications, and relevant coursework
UMUniversity of Málaga
Bachelor of Engineering, Industrial Engineering
2013 - 2020
Activities and societies: Advanced CFD Certificate (2018); Project Management (2019); Machine Learning (2021); English IELTS C1 (2021).
Industrial Engineering degree with a technical foundation in regulated product lifecycle management, focusing on full lifecycle project expertise and design assurance.
Tech stack
Software and tools used professionally
Availability
Location
BelgiumAuthorized to work in
Job categories
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