Product Development & Ingredient Innovations, Regulatory
4 Year Degree
The Product Development Regulatory Compliance Specialist is responsible for providing support to the Product Development Department ensuring all new raw materials, bulk product, and finished goods are qualified through documentation, laboratory testing, and other quality requirements. This position will work closely with other cross-functional departments and outside vendors. Additional responsibilities will include ensuring product labels and collateral comply with all applicable domestic and International regulations. This may include labeling artwork and copy, advertising, web content, product claims, and supplement fact panels.
In this role you will:
Organize and maintain raw material, bulk, and finished goods documentation
Learn and understand Nordic Naturals quality standards to ensure documentation is acceptable
Responsible for generating and controlling technical documentation for new products and existing product renovations
Continuously update and maintain domestic and International regulatory requirements
Review International label information to ensure regulatory compliance
Complete registration of new products with various certifying bodies
Assist with evaluation and qualification of new suppliers
Provide technical support for customer inquiries as needed
Establish and maintain relationships with external suppliers
Communicate information involving quality and/or manufacturing with external suppliers
Develop and maintain vendor scorecards
Lead investigations for Corrective and Preventative Action (CAPA) when involving products in the development pipeline, newly released products, or existing product renovations
Work with Quality Assurance and internal/third-party labs to define analytical, physical, and microbiological testing requirements
Source new raw materials and secondary/tertiary suppliers for existing raw materials
Seek out and implement continuous improvement initiatives to reduce NPD time to market, new/existing costing, and enhance product quality
Special tasks or projects, as assigned
Manage the creation, review, and approval of supplement facts panels, ingredient and allergen declarations, side panel information and required cautionary statements
Review product labels and marketing collateral for DSHEA compliance
Remain current with domestic food and dietary supplement labeling regulations and best practices (21 CFR 111, DSHEA, etc.)
Monitor the development and assess the impact of new and proposed changes in laws, rulings, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising
Support safety documentation and FDA New Dietary Ingredient (NDI) filings as required
Manage the submission of and tracks FDA 403(r)(6) 30-day notices for structure-function claims
BS degree in food science, chemistry, biology or related field required
2+ years of experience preferred in FDA regulated industry
Innovative and self-motivated, able to find a solution for or to deal proactively with work-related problems.
Critical thinker with a demonstrated ability to digest research and apply information
Working knowledge of the scientific method
Competent math skills
Strong interpersonal skills with the ability to use tact and diplomacy with other departments, including communication with off-site staff and suppliers
Clear verbal and written communication
In-depth working knowledge of FDA food and dietary supplement product regulations (21 CFR 111), guidance and policies, and a thorough understanding of the enforcement landscape
Strong attention to detail
Must be proficient with MS Office (especially excel)
This is a full time, in house position at our headquarters in Watsonville, California.
About Nordic Naturals
At Nordic Naturals, we’re committed to delivering the world’s safest, most effective nutrients essential to health. Our award-winning omega-3 fish oil and other foundational nutrients are research supported, expertly formulated, rigorously tested, proven effective and, best of all, great tasting. With products for the whole family, we deliver the nutrients essential for healthy living.
Nordic Naturals has been revolutionizing omega-3s since 1995, pioneering a new definition of fish oil as it relates to purity, freshness, taste, and dosage. Headquartered in Watsonville, CA, the company has expanded beyond solely omega-3s and offers complementary, foundational nutrients essential to health. Our portfolio, which is distributed to over 35 countries, includes more than 200 products in a variety of flavors and formulations for adults, kids, athletes, and pets. Family owned, Nordic Naturals works passionately to see generations of healthier, happier people around the world.
Nordic Naturals offers a great work environment, support for a healthy lifestyle, and an opportunity to be part of a company that’s making a positive difference. We are committed to the shared goal of promot...ing health and wellness by delivering the world’s safest, most effective omega oils. We see a growing worldwide market and need a great team of people to enable our company to continue to fulfill its mission.