Education: Bachelor’s degree in Food Science or related
Experience: 3-5 years’ experience in R&D or Quality Assurance/Food Regulatory related position. Experience in FDA regulatory compliance in terms of labeling, product development, and marketing. Experience in maintaining regulatory documentation. Experience in administrative functions for filing of certifications – Halal, Kosher, GMO, and Organic
Reports to Regulatory and Thermal Process Supervisor
Position Purpose and summary: As the Regulatory Affairs Specialist, provide and maintain regulatory documents and maintain product development software and databases to support the development of new products, packaging, labels, and processes under the guidance of the Regulatory and Thermal Process (RTP) Supervisor that meet and exceed our customer’s expectations. Provide technical support, resources, and services in a timely and efficient manner to all the company’s departments. As a back up to the RTP supervisor, provide regulatory expertise to the company as it pertains to the regulatory process. Also, provide back up for submissions of thermal process regulatory documentation to the State and Federal Agencies.
Develop innovative ideas and procedures that benefit our company, customers, & society, and promote the company’s reputation and integrity. Support the company’s business goals, programs, and procedures that achieve company goals and directives. Support the review, understanding, and compliance of all programs, policies, and procedures contained in the Food Safety and Quality Management System.
Duties and Responsibility: This role requires working within a cross-functional team and being comfortable in developing and maintaining a working relationship with other departmental team members and outside suppliers. This job entails daily problem solving accomplished by strong communication skills and being resourceful. It is essential to be detail oriented, as well as being inquisitive about the why and the how of the regulatory tasks. To get the job done, this role involves being able to influence others to provide the necessary and accurate information and being able to implement and manage their expectation.
Responsible for review of, and maintenance of Documentation including Product Specifications, Ingredient Statements, Nutritionals, and all other regulatory documents working under the guidance of the Regulatory and Thermal Process Supervisor as required to support sales and operations
Maintain and keep updated information in Product Vision
Provide instruction to the company’s members on how to use Product Vision, and make sure that it is being used properly and efficiently
Develop and maintain packaging information and labels
Field, track and complete regulatory requests for all products within the respective areas of CI&I responsibility and assign to appropriate departments
Develop and maintain internal company’s Ingredient Specifications
Work with Quality and Procurement on maintaining ingredient supplier information
Submit and manage Regulatory Filings/certifications of all New and Reformulated Products
Assist in the completion of regulatory requests for all products within the respective areas of CI&I responsibility.
Participate in Food Safety Meetings with Quality
Communicate with the scientists to assist with new ingredient sourcing and creating specifications.
Keep abreast of relevant local, state, and federal legislation, policies, and trends and support in areas of discovery and research.
External & Internal Relationships
Develop and maintain relationships with customers’ R&D & QA groups.
Develop and maintain relationships with internal QA groups.
Develop and maintain relationships with Marketing and Sales groups.
Develop and maintain a relationship with Corporate Chef.
Visit customers on an as-needed basis, with or without sales.
Provide technical support to customers regarding the Company’s products.
Other Duties and Responsibilities
Keep abreast of new
regulations that affect products and recommend for consideration where
Support the Regulatory
Supervisor as well CI&I team members as required.
Development and support of a
global regulatory program