Gabriela Is Ready for Her Next Regulatory Role

Gabriela Soriano - Professional Profile

Introduction

Gabriela Is Ready for Her Next Regulatory Role

6-year medtech RA specialist driving EU MDR compliance and faster approvals.

Dublin

About

I keep regulated products launchable when the rules, systems, and timelines change.

I have always been the person teams call when a submission is stuck, a technical file needs fixing, or an audit is getting close. I like the real work of regulatory, translating requirements into clear documentation and calm, cross-functional execution. Now I am focused on re-entering the Ireland market and contributing where compliance has to move fast without breaking trust.

I am at my best in the unglamorous, high-stakes middle, where teams need someone to turn requirements into inspection-ready proof. That includes building and maintaining EU MDR technical documentation, running GSPR traceability, and closing out Notified Body questions without drama.

I also bridge quality systems across regions. I have hands-on grounding in ISO 13485 and FDA 21 CFR 820, plus the habits that matter when frameworks evolve, like SOP discipline, record integrity, and training that actually sticks.

What makes me different is global execution. I have supported submissions and maintenance work across LATAM and multilingual environments, which helps multinational teams keep portfolios compliant across markets while the EU and US raise the bar at the same time.

If you know a hiring manager or team lead in Ireland working in RA, QA, or Regulatory Ops, I would value a warm intro. If introductions are hard, a LinkedIn share or a referral to an open role in medtech, diagnostics, biopharma, or RA/QA consulting would genuinely help.

Target roles: Regulatory Affairs Specialist, EU MDR/IVDR, QA/RA Compliance Specialist, ISO 13485 and FDA QSR/QMSR, Regulatory Operations Specialist, UDI/EUDAMED and document control

Get in Touch

Hi, I'm Gabriela. I'm a Regulatory Affairs Specialist with over 6 years of experience in medical device compliance and I'm excited about bridging international regulations to enhance patient safety. Would love to chat if you're working on medical devices or regulatory operations.

Gabriela Soriano linkedin.com/in/gabrielasoriano2

Gabriela is uniquely skilled in navigating complex regulatory landscapes, ensuring compliance and innovation in the medical device sector.