Label Compliance Specialist

3 weeks ago

West Valley City, United States Amare Global Full time
***Please note that this is HYBRID role where the ideal candidate will be required to work in our Lehi, UT office 1-2 days per week.***

As a Label Compliance Specialist at Amare Global, you will play a crucial role in ensuring that all product labels comply with regulatory requirements set forth by relevant authorities such as the FDA (Food and Drug Administration) and other regulatory bodies. Your attention to detail, and ability to collaborate cross-functionally will contribute to the success of our company and the safety of our consumers.

Responsibilities

  1. Regulatory Compliance: Work collaboratively with the Regulatory Manager to ensure that all product labels comply with FDA regulations, including but not limited to, the Dietary Supplement Health and Education Act (DSHEA), labeling guidelines, and other applicable regulations.
  2. Label Review and Approval: Review product labels for accuracy, completeness, and compliance with regulatory requirements. Work closely with cross-functional teams including regulatory affairs, product development, marketing, and legal to approve labels for new and existing products.
  3. Documentation Management: Maintain accurate records of label approvals and revisions. Organize and manage documentation related to label compliance to ensure accessibility and compliance with record-keeping requirements.
  4. Labeling Updates: Monitor regulatory changes and updates related to labeling requirements for dietary supplements. Implement necessary changes to labels to ensure compliance with new regulations and guidelines.
  5. Quality Assurance: Collaborate with quality assurance teams to ensure that label information accurately reflects product formulation and ingredient specifications. Participate in label verification processes to ensure alignment with product specifications and quality standards.
  6. Cross-Functional Collaboration: Work closely with various departments including regulatory affairs, marketing, product development, and legal to address labeling-related issues and provide guidance on regulatory requirements.
  7. Training and Education: Provide training and education to internal teams on labeling regulations, requirements, and best practices. Keep stakeholders informed of changes in regulatory landscape that may impact labeling processes and requirements.
  8. Audit Support: Assist in preparing for and participating in internal and external audits related to labeling compliance. Provide documentation and support as needed to demonstrate compliance with regulatory requirements.


Requirements

  • Strong attention to detail and ability to review and interpret complex regulatory documents and guidelines.
  • Excellent communication skills, both written and verbal, with the ability to effectively collaborate with cross-functional teams.
  • Proficiency in Microsoft Office Suite and experience with document management systems.
  • Ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment.
  • Certification in Regulatory Affairs (e.g., RAC) is a plus.
Benefits
  • Medical, Dental, Vision
  • 401k with match
  • Company sponsored income protection
  • Flexible Spending Accounts
  • Health Savings Account
  • 3 Weeks Paid Time off
  • 12 Paid Holidays

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