Regulatory Specialist

Role Responsibilities

• Plan and Program Development: Develop and implement (if applicable) FDA- compliant food safety plans or programs following Preventive Controls, HACCP, FSVP, and/or other regulatory requirements. Deliverables must meet our high-quality standards to ensure compliance and meet client needs.
• Regulatory Evaluation and Assessment: Evaluate ingredients, products, and processes to conduct hazard analysis or assessments from an FDA perspective. Review food safety records and compliance history to identify risk and gaps requiring corrective actions.
• Client Communication and Regulatory Support: Communicate directly and clearly with clients, their suppliers and the FDA, as applicable to the task. Provide clear, practical guidance on food safety concerns, corrective actions, and FDA regulatory requirements. Provide timely updates and support to clients.
• Documentation and Recordkeeping: Maintain accurate and complete records of client communications, including emails, calls, and interactions in designated systems. Organize and retain FDA-required documentation to support continuity, compliance, service delivery, and audit readiness, as applicable.

Required Skills and Experience

• Degree in Food Science & Technology, Food Safety, Microbiology, Biology, Chemistry or related science
• At least 2 years of experience working in regulatory affairs, quality control, or food safety compliance.
• Strong organization, problem-solving, and critical thinking skills.
• Fluent in English language (strong writing & oral skills) to communicate effectively and clearly with clients and FDA directly, as applicable.
• Ability to identify client needs and build relationships through a consultative approach.
• Quick adaptation to evolving technology systems.

Preferred Skills

• Training lor experience applying FDA requirements for food & beverage such as Preventive Controls, FSVP, HACCP, GMPs, or other.
• Training or experience applying food safety and quality standards such as FSSC 2200, SQF, BRC, or other.
• Other languages: Spanish Role & responsibilities

Shift Expectations

• EST time zone: 8.5 hours between 7am-5pm (candidate can choose after initial training period)