Regulatory Specialist

Position Title: Regulatory Specialist

Job Overview:

We are looking for a motivated, detail oriented, quality conscious Regulatory Specialist that will be responsible for managing and maintaining formula documentation, final product specifications, and regulatory registrations. This position requires high attention to detail as well as excellent organizational skills. The ideal candidate will be capable of working with minimal directions to assist departments with regulatory processes. The role will assist other departments, including product development. This position reports to the VP of Quality.

Key Responsibilities:

• Responsible for good documentation practices surveillance at the manufacturing facility along with the other QA/QC team members.
• Implement and continue to upkeep documentation per quality procedures.
• Support the VP, Quality in reviewing and approving US and International labels against the formulas to ensure accuracy.
• Review and approve formulas and final product specifications.
• Assist with change controls ensuring all documentation is updated.
• Review and approve Standard Operating Procedures (SOPS).
• Organize, file, and maintain controlled document files such as Certificates of Analysis and other cGMP logs/documents.
• Communicate with regulatory bodies to register products and schedule and assist with audits.
• Authority for acceptance/rejection of documentation based on their compliance with current specifications and government standards.
• Review Bill of Materials (BOMS) in Excel, Word and the electronic ERP system.
• Additional duties as needed.

Required Qualifications:

• Knowledge of FDA regulations for dietary supplements. Ability to learn FDA, FTC, and USDA regulations for Cosmetics and Food.
• Experience working in the food or supplement industry in a regulatory capacity is preferred.
• Background working directly with labeling is a plus.
• Ability to manage complex projects and juggle multiple priorities in a fast-paced environment and work well with cross-functional groups.
• 3 years in an administrative role is required.
• Strong interpersonal/communication skills.
• Proficiency in MS Office (Word/Excel).
• Excellent written and verbal communication.

Physical Requirements:

• Position may require the ingestion of our products as part of our product event / consumer complaint internal investigation and therefore any food allergies should be made known.
• This position will also require some use of the computer/ keyboard and sitting as well as use of other office equipment such as a phone and copier.

Additional Details & Benefits:

• Full-Time with competitive pay
• Health benefits package
• PTO
• 401(k)
• Progressive company environment, casual dress code, with a work hard/ play hard culture.
• Position located in Ogden, Utah.

Notice to Recruiters: We do not utilize outside recruiters. Please do not solicit.

The description of this role is not intended to be an exhaustive list of responsibilities and qualifications. The position, duties and qualifications are subject to change at any time.