ӗleeo brands is a household of thoughtful, high-quality, family-focused health & wellness brands that ensure a healthier, happier life is always within reach. We are seeking a Quality & Regulatory Affairs Manager for our Operations Team.

Job Description

The Manager of Regulatory Affairs & Quality will work directly with internal and external teams to ensure that all products meet quality and varying retail standards, are safe to use by consumers and that any human-related safety or regulatory-related copy claims and endorsements are allowable, tested and substantiated.

This position is also responsible for assuring all products comply with any applicable US and Canadian regulations and requirements. These include but are not limited to listing and maintaining products with the FDA (Cosmetic, Drug and Food and Supplement), EPA, FIFRA, CPSC, INDA and ongoing state-specific regulations and registrations.

This Manager is not expected to be expert in all regulatory and safety areas affecting the company, but can leverage outside consultants to inform the company’s regulatory and product safety needs and facilitate execution against these needs.

This individual is expected to be a team player and flex as needed based on broader team needs.

Responsibilities will include:

• 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
• 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,
• 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.

Qualifications/Requirements:

• Regulatory experience required, Quality and/or Operations experience preferred
• Project Management experience is not required but advantageous
• 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 Skills:

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

Interested candidates should forward their resume and references to [email protected] Regulatory Affairs & Quality Manager in the subject line.