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eleeo brands · 2 weeks ago

Regulatory Affairs and Quality Manager

Cincinnati, OH

Full-time

Onsite

Mid, Senior Level

eleeo brands is a collection of family-focused household, health & wellness brands. The Regulatory Affairs and Quality Manager will ensure that all products meet quality and regulatory standards, collaborating with internal and external teams to manage compliance with US and Canadian regulations.

BabyConsumer GoodsWholesale

Responsibilities

Proactively and positively work with and serve as a resource to the operations, quality, product development and marketing teams

Onboard new and existing suppliers with Supplier Standards, maintain a repository of documents provided and ask suppliers for updated documents as needed

Work with internal and external stakeholders to track and approve finished good quality documentation and investigate and resolve product quality issues if they arise

Collaborate with suppliers and formulators to identify acceptable raw material alternatives and replacements in order to react to supply chain disruptions and/or identify cost saving opportunities

Manage and develop regulatory & quality documentation across all products and raw materials (SDS, Formula Cards, Certificates of Analysis, Spec Sheets, Naturally Derived Statements, etc; with consultative or 3rd party support if needed)

Assist in new product development, reviewing all potential raw materials and formulas, and labels against key internal and external policies, standards and regulations

Inform and provide guidance on all labeling and marketing copy and manage internal processes for tracking and substantiation: claims, cautionary statements, use directions, drug facts, supplement facts, DOT regulations, etc

Ensure all products fully comply with related Federal and State regulations (FDA Cosmetics, FDA Drugs, FDA Food, EPA and Cleaning Product Regulations)

Ensure all products and business practices fully comply with varying retailer requirements and coordinate related testing if needed

Ensure all data, product certifications, SDSs, and other key information are loaded into and reflected correctly on our website(s) and other online portals like WERCS, SmarterX and Label Insights

Relay, manage and coordinate any required product testing: claims, endorsements (i.e. Clean Label Project, USDA Organic, Non-GMO), performance, safety/toxicity, micro, human testing, retail compliance, etc

Manage regulatory related licenses and registration (i.e. Oregon Board of Pharmacy)

Manage product formulation, regulatory and safety inquiries that come from retailers, consumers, suppliers or other external parties

Proactively track (with the help of outside consultants and via participation in trade associations) the key regulatory trends that could impact the business and summarize potential implications and recommendations regarding these trends

Qualification

Regulatory experienceQuality managementConsumer packaged goodsMicrosoft OfficeGoogle for BusinessesOrganic Product CertificationProduct Labelling RegulationsDirect othersBachelor's DegreeSolid organizational skillsAttention to detailCommunication skills

Required

Regulatory experience required, Quality and/or Operations experience preferred

Consumer packaged goods industry experience

Strong working knowledge of Microsoft Office & Google for Businesses

Solid organizational skills and attention to detail

Excellent written and verbal communication skills

Lead and direct the work of others and manage up if needed

Bachelor's Degree in appropriate field of study or equivalent work experience

Preferred

Knowledgeable in Organic Product Certification and Labelling Standards under USDA and NSF/ANSI 305

Familiar with Product Labelling/Claims Regulations in the Food, Cosmetics and Cleaning Products areas (FDA, MoCRA, CPSC, Prop 65, CA SB258 among others)

Experience with similar International Regulations is a plus

Previous knowledge of FDA online reporting portals (FEI, NDC, MoCRA, SPL, COSM, 510k Device) is a plus