Regulatory Affairs Specialist Health Genesis Corp - 2.4 Davie, FL Job Details Full-time 1 hour ago Benefits Health insurance Dental insurance Paid time off Employee assistance program Vision insurance Employee discount Life insurance Qualifications Biology New product introduction engineering projects Preventive action implementation Production deviation management Corrective and preventive actions (CAPA) Internal investigations Project management experience in manufacturing Change management Supplier audits Manufacturing facility experience Supplier audit compliance assessment Attention to detail Internal compliance assessments Regulatory/legal compliance standards in production Biomedical regulatory compliance Managing projects Training & development Research and development project management Standard operating procedures (SOPs) Manufacturing company experience Cross-functional communication Supplier quality assurance (SQA) FDA regulations Audit support Analytics Full Job Description We are seeking an experienced Regulatory Affairs Specialist to lead and support Product Development, Research & Development (R D), Quality Assurance, Quality Control, and Regulatory Affairs within a nutraceutical manufacturing environment. This role is responsible for supporting new product development and commercialization, strengthening quality systems, overseeing regulatory compliance, and ensuring operations meet FDA, cGMP, applicable 21 CFR requirements , and industry certification standards. The ideal candidate has strong experience in nutraceutical manufacturing, quality systems, regulatory compliance, product development, and cross-functional project management. Key ResponsibilitiesProduct Development & R D Support new product development projects from development through commercialization. Manage projects involving dietary supplements, gummies, liquids, capsules, powders, tablets, OTC products, and other dosage forms. Ensure development activities meet quality, manufacturing, regulatory, and business requirements. Coordinate with R D, QA/QC, Production, Operations, Marketing, and Sales to support successful product launches. Support laboratory activities, including testing, sample management, product evaluation, documentation, and data review. Provide technical support and resolve product, process, manufacturing, and commercialization challenges. Monitor market trends, regulatory developments, competitor activity, and industry technologies. Prepare technical reports, investigations, assessments, and development documentation. Quality Assurance & Quality Control Ensure compliance with FDA regulations, cGMP requirements, company procedures, and quality standards. Maintain compliance with applicable 21 CFR requirements, including Parts 101 and 111 . Develop, review, revise, and implement QA/QC, laboratory, R D, and GMP SOPs. Maintain accurate, complete, controlled, and traceable quality documentation. Participate in Material Review Board (MRB) investigations and disposition decisions. Review specifications, receiving records, master manufacturing records, batch records, complaints, investigations, and product returns. Support disposition of rejected or nonconforming materials and finished products. Manage supplier qualification documentation and maintain the Approved Supplier List. Support investigations involving deviations, complaints, discrepancies, and nonconformances. Participate in mock recalls and support GMP-compliant manufacturing, packaging, labeling, storage, and holding operations. Regulatory Compliance & Audits Maintain compliance with FDA, c

GMP, 21 CFR

Parts 101 and 111 , and other applicable dietary supplement and OTC requirements. Support compliance with NSF, CCOF, EcoCert, OSHA, and other applicable regulatory or certification standards. Participate in internal, external, customer, supplier, certification, and regulatory audits. Conduct gap analyses and support audit preparation, corrective actions, and follow-up. Maintain audit readiness across Quality and R D operations. Monitor regulatory changes and support implementation of required updates. Validation & Quality Systems Support cleaning validation, sanitation, stability, calibration, environmental monitoring, temperature mapping, and water system programs. Support

IQ/OQ/PQ

documentation and equipment qualification activities. Assist with investigation and timely closure of deviations, CAPAs, and nonconformances. Support change control activities and ensure changes are properly evaluated, documented, approved, and implemented. Identify quality trends and recommend corrective, preventive, and continuous improvement actions. Training, Metrics & Continuous Improvement Lead and support cGMP, QA/QC, laboratory, regulatory, and operational training. Ensure required training is current and properly documented. Develop, track, and report quality metrics and KPIs. Monitor CAPAs, deviations, complaints, change controls, SOPs, audits, environmental monitoring, and other quality systems. Prepare quality trend reports and management review presentations. Support continuous improvement initiatives across Quality, R D, Production, Warehouse, and Operations. Labeling & Commercial Compliance Review dietary supplement product labels and packaging for compliance with applicable FDA requirements. Review Supplement Facts panels, ingredient declarations, warnings, directions for use, claims, and other labeling elements. Review marketing materials for compliance with applicable FDA, FTC, and internal requirements. Support regulatory review of new products, packaging changes, product updates, and commercial materials. Collaborate with Product Development, Marketing, Sales, Operations, and Production to support compliant commercialization. Qualifications Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Food Science, Engineering, Quality, or a related scientific or technical field. Previous experience in the dietary supplement or nutraceutical manufacturing industry . Strong knowledge of FDA regulations, cGMP requirements, and applicable 21 CFR regulations . Knowledge of 21 CFR Part 111 required or strongly preferred. Knowledge of 21 CFR Part 101 and dietary supplement labeling requirements preferred. Experience with Quality Management Systems, SOPs, CAPAs, deviations, change controls, complaints, investigations, and audits. Experience supporting or leading new product development and commercialization projects. Experience participating in regulatory, certification, supplier, customer, or internal audits. Strong analytical, documentation, investigation, and problem-solving skills. Ability to manage multiple projects and priorities in a fast-paced manufacturing environment. Strong organizational and communication skills. Ability to work effectively with cross-functional teams and all levels of management. Preferred Qualifications Experience with gummies, liquids, capsules, powders, tablets, or OTC products. Knowledge of NSF, CCOF, EcoCert, or similar certification programs. Experience with stability programs, validation, environmental monitoring, supplier qualification, and laboratory operations. Previous supervisory or cross-functional leadership experience. What We Are Looking For We are looking for a proactive, organized, and detail-oriented professional who can effectively balance product development, quality, regulatory compliance, and operational execution . The successful candidate will be comfortable managing multiple priorities, collaborating across departments, solving technical and quality challenges, and supporting a strong culture of compliance and continuous improvement.

Benefits:

Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person