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Helen will
@will_hellen
FDA Compliance Expert, US Agent, FSVP, 510k, Import Clearance Specialist
Vereinigte Staaten
Englisch
Über mich
Entering the U.S. market requires more than just FDA registration, it requires getting it right with the right expert like myself. I help international brands and manufacturers navigate FDA compliance for food, cosmetics, supplements, and medical devices with accuracy and clarity.
From FDA Facility registration and U.S. Agent support to FSVP, Prior Notice, labeling, and device listing/510(k), I ensure your product meets FDA requirements and clears import smoothly. Reliable, compliant, and handled the right way from day one. SEND A MESSAGE NOW OR PLACE AN ORDER TO GET STARTED, THANKS.
Kompetenzen
Helen will
offline •
Durchschnittliche Antwortzeit: 2 Stunden
Meine Dienstleistungen
Gewerbeanmeldung
I will do fda food facility registration fda compliance US agent services fda lawyer
Social-Media-Management
I will do mhra registration ukca certificate fda compliance and mdr documentation
Portfolio
Arbeitserfahrung
FDA Regulatory Affairs Associate
Abbott • Freiberufler
Dec 2024 - Present • 1 yr 7 mos
Supported FDA regulatory compliance activities for medical devices, diagnostics, and healthcare products. Assisted in preparing and maintaining FDA Establishment Registrations, Device Listings, 510(k) submissions, regulatory documentation, labeling compliance reviews, and post-market regulatory requirements. Collaborated with cross-functional teams including Quality Assurance, Research & Development, Manufacturing, and Marketing to ensure products met FDA regulations and industry standards. Contributed to successful product registrations, regulatory submissions, and compliance initiatives that supported product launches and continued market access in the United States.
Regulatory Affairs Specialist
Pfizer • Freiberufler
Jan 2020 - Jun 2023 • 3 yrs 5 mos
Provided FDA regulatory consulting services to food manufacturers, dietary supplement brands, cosmetic companies, medical device manufacturers, and importers seeking entry into the U.S. market. Successfully managed FDA Facility Registration, U.S. Agent Services, FSVP Compliance, Prior Notice Submissions, FDA Label Reviews, Medical Device Establishment Registration, Device Listing, and 510(k) premarket submissions. Assisted clients with FDA import compliance, warning letter responses, and regulatory strategies that helped products meet FDA requirements and enter the U.S. market efficiently. Supported over 200 regulatory projects across multiple industries while maintaining high standards of compliance and client satisfaction.
Medical Device Regulatory Specialist
Medtronic • Vollzeit
Feb 2018 - Jun 2022 • 4 yrs 4 mos
Supported regulatory affairs activities for medical devices marketed in the United States and international markets. Prepared and maintained FDA submissions, establishment registrations, device listings, technical documentation, and regulatory compliance records. Collaborated with quality assurance, engineering, and product development teams to ensure compliance with FDA regulations, Quality System Regulations (QSR), and applicable international standards. Assisted with 510(k) submissions, labeling reviews, post-market compliance activities, and regulatory strategies for product launches. Contributed to successful regulatory approvals and ongoing compliance for multiple medical device product lines.
