What are the responsibilities and job description for the Regulatory Compliance Administrator position at Universal Nutrition?
Regulatory Compliance Administrator
Job Description
Qualifications and Skills
- A minimum of a bachelor’s degree
- 1-2 years of experience in regulatory compliance, preferably in the dietary supplements or food industry.
- In-depth knowledge of regulations such as FDA cGMPs (21 CFR Part 111), and international standards (e.g. Health Canada).
- Must be able to work independently
- Strong analytical, organizational, and attention-to-details.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office and Excel.
Summary
The Regulatory Compliance Administrator is responsible for ensuring that all applicable regulatory standards and guidelines are met. This role involves maintaining compliance with regulations under FDA (21 CFR part 111), managing product documentation, and supporting the quality team to ensure regulatory compliance.
Responsibilities:
- Review labels against formulas and authorize changes to ensure all products labels meet FDA requirements, including ingredient declarations, claims, and allergen statements.
- Receive and document complaints and perform investigations.
- Review product returns and provide disposition.
- Provide reports and data analysis of complaints on a monthly basis during Quality Meetings.
- Monitor regulatory changes (domestic and international) and recommend updates to the quality assurance team as needed.
- Review company SOPs and conduct internal quality audits when needed.
- Take on project work as needed to maintain third party certifications.
- Participate and support managers in third party and FDA audits.
- Perform other quality duties as assigned.