Regulatory Affairs Specialist I

We are seeking a detail-oriented Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in compliance management, FDA regulations, and quality assurance within the pharmaceutical or medical device industry.

Responsibilities:

Labeling & Artwork Compliance

• Conduct label proof reviews and approvals for new and revised artwork.
• Approve shipment labels and ensure printed materials meet FDA, FTC, and customer-specific requirements.
• Advise internal teams and customers on compliant claims, ingredient statements, warnings, and required labeling elements.
• Maintain inventory control of consumer labels, including version control, status updates, and releasing first-print runs of new labels.

Supplier Qualification & Raw Material Compliance

• Manage and maintain qualification records for all suppliers, manufacturers, and outsourced manufacturing services including surveys, certifications, allergen statements, and compliance documentation.
• Review and approve raw material for regulatory alignment, quality requirements, and allergen/contaminant control.
• Assign and manage corporate commodity codes for raw materials and formulas (bulk and packaging) to ensure proper allergen tracking and regulatory classification.
• Review and approve raw materials and formulas within internal systems (QMS, Monday.com) from a regulatory perspective.

Regulatory Submissions & Registrations

• Prepare and manage regulatory registrations and permits with applicable agencies (FDA, state health departments, environmental reporting bodies).
• Handle environmental and hazardous waste-related submissions including- CERS, and eVQ – Hazardous Waste
• Prepare and submit FDA Structure/Function Claim Notifications for key retailers (Walmart, Costco, etc.).
• Complete WERCS submissions for safety documentation, SDS alignment, and retailer compliance.

Customer Quality & Regulatory Support

• Serve as the primary point of contact for all customer Quality and Regulatory departments for documentation requests, compliance questions, and escalated concerns.
• Respond to regulatory inquiries and supply required documentation such as certifications, statements, allergen declarations, and compliance attestations.
• Complete customer questionnaires for onboarding and ongoing vendor compliance.
• Participate in Costco safety calls, coordinate follow-ups, and participate in customer-driven escalations.

Quality & Food Safety Program Support

• Prepare for third-party and customer audits by ensuring all SOPs, training records, permits, and certifications are current, organized, and audit-ready. Lead back-room audit operations by coordinating documentation, managing requests, and supporting the Quality team during front-room audit activities.
• Develop and maintain HACCP documentation, including- HACCP Manufacturing Maps, HACCP Plans, and Hazard Analysis
• Maintain Seafood HACCP / GMP–Trident food safety programs.
• Review deviations and non-conformances from a regulatory compliance perspective and disposition as needed.

Regulatory Strategy & Cross-Functional Leadership

• Develop regulatory strategies to support new product development, formula changes, and market expansion.
• Provide proactive regulatory guidance to R&D, QA, Procurement, and Marketing during product concept stages to prevent compliance risks or delays.
• Lead regulatory risk assessments for ingredients, claims, and formulas.

Oversight, Governance & Team Leadership

• Establish and enforce regulatory policies, SOPs, and internal compliance standards.
• Mentor and guide junior regulatory staff; review and validate their work for accuracy and consistency.
• Provide final approval on high-risk regulatory decisions involving claims, novel ingredients, or sensitive formulations.

Regulatory Intelligence & Monitoring

• Monitor evolving regulations (FDA, FTC, DSHEA, FSMA, Prop 65, state-level laws, retailer policies).
• Communicate regulatory changes and compliance requirements to leadership and cross-functional teams.
• Update internal procedures and compliance programs as regulations evolve.

Product Lifecycle & Change Management

• Oversee regulatory compliance throughout the entire product lifecycle from concept to launch to post-market monitoring.
• Evaluate the regulatory impact of formula changes, ingredient substitutions, or supplier transitions.
• Ensure all product revisions remain compliant and determine when re-submission or re-notification is required.

Retailer Compliance Management

• Lead regulatory interactions with major retailers (Costco, Walmart, etc.).
• Oversee portal submissions, documentation updates, and responses to escalated retailer requests.
• Ensure compliance with all retailer-specific formulation, labeling, and documentation requirements.

Compliance Risk Management

• Conduct regulatory risk assessments for ingredients, suppliers, manufacturing processes, claims, and formulations.
• Develop corrective action plans for identified compliance gaps.
• Lead regulatory investigations for escalated customer complaints and safety concerns.

External Regulatory Interaction

• Act as the primary regulatory contact for government agencies and regulatory bodies.
• Coordinate and prepare official responses to inspections, inquiries, and enforcement actions.
• Oversee preparation and submission of regulatory dossiers and formal letters.

Training & Internal Education

• Develop and deliver regulatory training to cross-functional teams (Marketing, R&D, QA, Customer Service, Procurement).
• Promote regulatory awareness across the organization and enhance cross-departmental compliance understanding.

Post-Market Surveillance & Safety

• Monitor adverse event trends, safety reports, and regulatory alerts related to ingredients or product categories.
• Partner with QA to review complaint data and determine if regulatory reporting or safety actions are required.
• Implement processes for ongoing post-market compliance.

Qualifications:

• Bachelor's degree in technical discipline; or 5 years related experience and/or training; or equivalent combination of education and experience.
• Minimum 5 years experience in dietary supplement industry with a minimum of 2 years in Regulatory Affairs.
• regulatory affairs within the pharmaceutical or medical device industry.
• Strong knowledge of FDA regulations and guidelines.
• Excellent project management skills.
• Advanced proofreading skills (professional level).
• Knowledge of Food and Drug Administration regulations and guidelines including 21CFR Part 111 & Part 117.
• Excellent verbal and written communication skills.
• Proficient in Microsoft Office products; Excel, Word, Outlook, etc.
• Ability to work effectively in a team environment.

If you are looking to advance your career in regulatory affairs and contribute to the development of life-changing products, we encourage you to apply.

Job Type: Full-time

Pay: $70,000.00 - $82,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Ability to Relocate:

• Tustin, CA 92780: Relocate before starting work (Preferred)

Work Location: In person

Salary : $70,000 - $82,000