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FDA Regulatory Compliance Consultant

My Sasun • Temps plein

Jul 2025 - Present • 1 yr 3 mos

I work as an FDA Regulatory Compliance Consultant at Mysasun, helping businesses understand and meet FDA requirements for bringing their products into the U.S. market. I handle different types of FDA projects, from registrations and product listings to regulatory research, classification, labeling, and import compliance. I’ve worked on projects involving pharmaceuticals, medical devices, food, cosmetics, and dietary supplements, assisting clients with requirements such as FDA facility registration, product registration and listing, U.S. Agent requirements, NDC registration, 510(k) support, GUDID, FSVP, Prior Notice, and MoCRA compliance. I also work on the import side of compliance, helping clients prepare FDA-related documentation, review importer requirements, and coordinate with customs brokers and logistics companies when products are being shipped into the United States. A big part of my role is researching each client's specific situation, identifying what FDA requirements apply to their products, and guiding them through the process step by step so they can move forward with confidence and avoid unnecessary compliance issues.