FDA Regulatory Specialist

  • Anywhere

Company :

Location :
Melrose Park, New York

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

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Description :
Description The FDA Regulatory Specialist manages the process for collecting, reviewing, and revising the ingredients and nutritional data for potential food components and their related packaging needs. Maintain Genesis database and corresponding spreadsheets with regulatory information in compliance with US FDA standards. Complete label information and nutritional data forms needed by our retail and licensor partners. Ensure that ingredients and nutritional statements on production art files, printed material and web-based data are 100% accurate and comply with FDA labeling regulations. The individual in this role assists the Director of FDA Labeling and Compliance with research on labeling compliance issues as needed. Contact food companies to obtain current ingredient, allergen, nutritional, and COO information including 100g raw data sheets. Revise wording of both mandatory and advisory allergen statements to be both compliant and consistent per retailer/licensor requirements. Check nutritional data to see that serving size and servings per container have been calculated correctly according to FDA rules for reference amounts and discrete units and that rounding rules have been followed. Check that rounding rules have been followed for all nutrients, RDIs, and DV percentages Maintain Regulatory Compliance Database. Incorporate all information gathered into Genesis software system, creating nutrition/ingredient/allergen reports for use on DesignPac packaging designs Enter preparation instructions for all products requiring further steps in order to be complete. Manage overall label compliance for packages. Confirm PDP calculations for font size regulations. Determine if product statements of identity and supplemental statements are correctly worded. Recommend any additional safety warnings/safe handling instructions/disclaimers that should be added. Check declaration of net contents for accuracy and correct set up. Determine nutritional panel for each package. Recommend the correct format of nutritional panel to use based on the available display space as well as the regulations regarding the nutritional values in the product. Understand and communicate to the team on which nutrition panel formats should be used and when: simplified, shortened, aggregate, tabular, linear, dual Ensure that panel templates follow font and point size regulations Confirm accuracy of recipes/ prep instructions. As needed, test the preparation instructions to determine if the wording is customer friendly and if the finished product comes out as expected. Revise wording of recipes and prep instructions as needed for ease of customer understanding and also for retailer/licensor conformity Review production artwork files. Proof component boxes for accuracy of ingredients and nutritional statements Check that all mandatory information is listed and is in correct order. Check that retailer/licensor specific requirements have been followed Requirements Bachelor Degree in Nutrition, Food Science, Biology or related discipline required At least 3-5 years of experience with Food Labeling, Quality and R & D Specialized training in Food Labeling is a plus Excellent computer skills, must be proficient in Microsoft Word and Excel and Genesis as well as internet research abilities Strong written and verbal communication skills Knowledge of FDA and USDA regulations for food products Food manufacturing and nutrition knowledge Internet research abilities Ability to manage complex projects and juggle multiple priorities in a fast-paced environment and work well with cross-functional groups. Detail-oriented, excellent problem-solving skills and resourcefulness Manage projects and time efficiently About Us DesignPac Gifts, LLC designs, assembles, and distributes gourmet food gifts. The company offers candies, wines and spirits, and seasonal products. It markets its gifts and decorative accessories to retail stores in the United States and internationally. The company was founded in 1991 and is based in Melrose Park, Illinois. As of April 30, 2008, DesignPac Gifts, LLC operates as a subsidiary of , Inc.