Ally Gonzalez
Regulatory Affairs Project Manager @ MedEnvoy Global | MedTech Compliance & Regulatory Operations
- Role
- Regulatory Affairs Project Manager at Medenvoy Global
- Location
- Austin, TX, US
- LinkedIn followers
- 500 followers
About Ally Gonzalez
As a Regulatory Affairs Project Manager at MedEnvoy Global, I support medical device and IVD manufacturers with EU, UK, and Swiss market access under evolving frameworks like the EU MDR and IVDR. My role includes managing onboarding and regulatory documentation, overseeing communication with Competent Authorities, and ensuring alignment with post-market surveillance, vigilance, and labeling requirements. I serve as a central liaison between internal teams and client stakeholders to keep projects on track and audit-ready.With a background in client-facing and operational roles, I bring a service-driven mindset and the ability to navigate complex regulatory processes with precision and care.I\'m focused on growing within the regulatory space and building a strong network of industry professionals dedicated to improving healthcare globally.
Experience
Regulatory Affairs Project Manager
May 2025 — Present
Education
The University of Texas at San Antonio
Bachelor's degree, Kinesiology
2015 — 2020
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