Regulatory Specialist II (Biotech)

This position is responsible for providing food labeling expertise and collaborate cross-functionally within The Krusteaz Company to support business needs and ensure regulatory compliance. This position manages communication of nutritional labeling reviews and information requests for both internal and external customers. This position serves as a resource for labeling and food based regulatory questions for KCO personnel, and addressing regulatory issues pertaining to food labeling that arise across the company.

Essential Functions: Other duties, responsibilities, and activities may change or be assigned at any time.

• Develop and implement standards and work processes to ensure an effective and consistent regulatory review process is executed for all KCO and customer products.
• Partner cross-functionally with Business Teams and R&D to proactively identify and create opportunities for labeling, claims, ingredients and innovative product claims and positioning that influence the business strategy.
• Build relationships with and utilize external regulatory consultants to leverage support for unique regulatory questions and international market compliance.
• Use KCO systems, policies and tools and as the primary user, contribute to their maintenance and identify improvement opportunities.
• Analyze, review, update and approve raw material technical data for input and spotting any inconsistencies or possible errors in documentation.
• Prepare and develop legally mandated label copy and maintain appropriate substantiated documentation.
• Develop ingredient statements and ensures products meet appropriate FDA/USDA standard of identities.
• Develop Nutrition Facts Panels for assigned products, ensuring compliance with all applicable labeling related regulations, including but not limited to all nutrient, health, and wellness claims.
• Ensure that products are in compliance with regulations and KCO policies with respect to formulas, product labeling and company communication (advertising, promotional materials, websites, etc.)/
• Analyze, review, update, translate and approve product technical data into consumer information for the process of labeling technical copy with inputs for packaging.
• Inform, updated, and communicate to cross-functional teams on matters relating to projects status, product labeling or compliance concerns that may affect the specific business initiatives being worked on.
• Stay current of nutrition and regulatory developments and identify opportunities and implications to the business.

Position Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals qualified with disabilities to perform the essential functions.

• Creates an environment that encourages teamwork and collaboration.
• Excellent problem-solving skills, able to work with others as needed to resolve.
• Willingness to challenge the status quo and ignite change by actively sharing proven ideas and technologies.
• Excellent project and time management skills. Self-directed with minimal supervision.
• Strong written, oral, and facilitation skills.
• Ability to evaluate and communicate project status, issues or risk appropriately.
• Conveys technical information in understandable terms to all levels of the organization.
• Strong understanding of FDA regulations required, understanding of Canadian, Mexican, EU a plus.
• Ability to perform thorough research on regulatory topics.
• Development experience in multiple product categories, dry mix products including baking, frozen, and/or beverage is a plus.
• Strong background in ingredient application.
• Leverage external resources (suppliers, co-mans, consultants and service providers).
• Independent execution of projects, ability to determine next steps.
• Ability to apply insights using understanding of common consumer and market research.
• Proficient in Microsoft Office and other computer applications.
• High integrity and honesty, promoting trust in all actions.
• Enjoys working in a results-oriented, customer focused, team environment.
• Ability to turn around projects at a fast pace.
• Creative and change-oriented, willing to constructively challenge the status quo.
• Willingness and ability to travel less than 10%.

Education and/or Experience:

• B.S. or M.S in Food Science or related field, or equivalent experience/training.
• Minimum 5+ years' progressive regulatory experience.

Physical Demands and Work Environment:

While performing the duties of this job, the employee is regularly required to stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone along with reaching. Specific vision abilities include close vision requirements due to computer work. Moderate noise, ability to work in a confined area, and ability to sit at a computer for an extended period of time are also included.

The policy of The Krusteaz Company is to hire, train, and promote all persons in all job groups in accordance with law, without regard to race, color, religion, sex, sexual orientation, age, marital or military status, national origin, gender identity, the presence of any sensory, mental or physical disability, genetic information, or any other status or characteristic protected by local, state, or federal law.

Get to know us:

• A people-focused company that cares: We're a 90-year-old company with the entrepreneurial spirit of a startup and a focused eye on the future. As a midsized, privately held company with a portfolio of beloved food and beverage brands, our people are the most important ingredient in our success.
• A valued and supported workforce: We place tremendous value in our employees and provide competitive pay and comprehensive benefits to ensure our employees can create the best life for themselves. Benefits include a top tier health insurance plan with lower-than-average employee cost share, generous PTO, 401(k) match, and more.
• An engaged and energized culture: At The Krusteaz Company, collaboration and ingenuity drive our fierce commitment to creating extraordinary product experiences that people love.
• A place to grow and make a difference: An entrepreneurial spirit has been at the core of our company since the beginning, attracting self-starters who are curious and love to learn and to share ideas.

Hybrid Work Model: At The Krusteaz Company, we have in-office "core days" of Tuesdays and Wednesdays where all corporate employees are expected to be onsite. Mondays, Thursdays, and Fridays are flexible remote days to allow for work/life balance. You may be asked to come in outside of a core day from time to time, based on business needs. We have found aligning our scheduled in-office days provides opportunity for employees to build connections and collaborate together.

Benefits: We are proud to offer generous benefits including comprehensive medical, dental, and vision insurance (starting at $60-$95/month for employee-only coverage on the PPO Plan or starting at $30-$45/month for employee-only coverage on the HDHP), 401(K) matching, 3 weeks of paid time off, 10 paid holidays, 1 paid personal holiday, company provided life insurance and disability insurance, flexible spending account, healthcare saving account, voluntary accident insurance, voluntary critical illness insurance, and tuition reimbursement. For those residing in Washington State, hourly employees accrue paid sick time at a rate of 1 hour for every 40 hours worked under Washington Paid Sick Leave, which is tracked as a subset of paid time off.

Salary Information: An employee in this position can expect a salary range between $76,785.00 and $122,858.00. We typically pay out between $85,000.00 and $108,000.00 The actual salary offered will carefully consider a wide range of factors, including internal equity, experience, education, certification, training, and location. All positions are eligible for additional incentives based on business performance.

We hope you'll take the time to get to know us!

The Krusteaz Company is not sponsoring new applicant employment authorization at this time and please, no third-party recruiters.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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