Barbara

Medical Device Regulatory Specialist

Medical Group Care • Freiberufler

May 2018 - Present • 8 yrs 4 mos

Supported medical device manufacturers with FDA regulatory strategy, FDA 510(k) submissions, device listing, UDI/GUDID registration, quality documentation review, labeling compliance, and regulatory gap assessments. Assisted clients in preparing submission-ready documentation while ensuring compliance with applicable FDA regulations.

Senior FDA Regulatory Affairs Consultant

John's Workshop • Freiberufler

Jan 2021 - Jul 2026 • 5 yrs 6 mos

Lead FDA regulatory projects for food, medical device, cosmetic, pharmaceutical, and dietary supplement manufacturers. Prepare FDA registrations, facility listings, FDA 510(k) documentation, U.S. Agent representation, MoCRA compliance, labeling reviews, import documentation, NDC listings, UDI/GUDID submissions, and regulatory strategies for domestic and international businesses seeking market access in the United States.

FDA Food & Import Compliance Consultant

Food and Agriculture Organization of the United Nations • Freiberufler

Dec 2019 - Jul 2026 • 6 yrs 7 mos

Worked with food manufacturers, beverage companies, importers, exporters, and private label brands to complete FDA Food Facility Registration, Prior Notice submissions, FSVP compliance, FDA labeling reviews, U.S. Agent services, import documentation, and regulatory consulting to support successful entry into the U.S. market.