Regulation Affairs Specialist

Description

DrVita, Inc. is seeking an experienced Regulatory Affairs Specialist to support regulatory compliance for our dietary supplement products and manufacturing operations.

This position is responsible for ensuring compliance with FDA regulations, DSHEA, and 21 CFR Part 111 cGMP requirements. The Regulatory Affairs Specialist will review product labels and claims, maintain regulatory documentation, support audits and certifications, and provide regulatory guidance to R&D, Quality, Marketing, and other departments.

• Ensure compliance with FDA, DSHEA, and 21 CFR Part 111 cGMP requirements.
• Review product labels, Supplement Facts panels, ingredients, and marketing claims.
• Evaluate regulatory risks for new products, formulations, and ingredients.
• Maintain regulatory SOPs, product specifications, SDS files, and controlled documentation.
• Support Document Control and Change Control activities.
• Complete customer regulatory questionnaires and documentation requests.
• Support regulatory, customer, and third-party certification audits.
• Assist with registrations, licenses, corrective actions, and regulatory inspections.
• Provide regulatory guidance to R&D, Quality, Marketing, and other departments.

• Collaborative team that values practical solutions and continuous improvement.
• Stable, full-time schedule with a focus on work-life balance.
• We offer a comprehensive benefits package to employees and their families.
• Flexible Spending Account & Health Savings Account options
• Voluntary Life Insurance
• Short-Term& Long-Term Disability
• 401(k) Plan with up to 6% Match
• Paid Time Off
• Paid Holidays (8 holidays)
• Quarterly Vitamin Allowance (up to $150)
• Employee Wellness Program
• Performance based spot bonuses

Final candidate will be required to successfully complete a pre-employment background check and drug screening, as condition of employment in a GMP-regulated facility.

• Bachelor's degree in Regulatory Affairs, Food Science, Biology, Chemistry, Life Sciences, or related field preferred; equivalent experience may be considered.
• 3-5 years of regulatory, quality, or compliance experience in a regulated manufacturing environment.
• Knowledge of FDA dietary supplement regulations, DSHEA, and 21 CFR Part 111.
• Experience with dietary supplement labeling and claims preferred.
• Strong technical writing, organization, analytical, and communication skills.
• Proficiency with Microsoft Office and electronic document or quality management systems.
• Experience with NSF, USP, Organic, Non-GMO, Kosher, or Halal certifications is a plus.