
MASON
FDA and EPA Regulatory Consultant 510k, FDA Registration, Labeling
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Experiência profissional
Regulatory Affairs Consultant
Udemy • Autônomo
Jun 2022 - Present • 4 yrs
I provide regulatory affairs and compliance consulting services for startups, manufacturers, importers, and international businesses. My experience includes: • FDA 510(k) submission support • FDA Establishment Registration and Device Listing • FDA labeling and UDI compliance guidance • OTC drug and cosmetic compliance assistance • EPA FIFRA pesticide registration support • CBER biologics regulatory assistance • DUNS number and compliance documentation support • EU and international business registration assistance I assist clients with regulatory documentation, compliance preparation, and submission guidance to help businesses meet regulatory requirements efficiently and professionally. I focus on clear communication, detail-oriented work, and practical compliance support tailored to each project.