Regulatory Compliance Manager

Regulatory Compliance • Lead all compliance activities for food-contact packaging materials and finished products. • Interpret, implement, and maintain compliance with applicable regulatory requirements, including US FDA 21 CFR, EU Food Contact Material Regulations, China GB standards, UK Food Contact Regulations, Swiss Ordinance, and customer-specific requirements. • Monitor regulatory changes, assess business impact, and communicate relevant updates to internal stakeholders. • Maintain regulatory registers, compliance matrices, and legal requirements databases. • Review, prepare, approve, and maintain Declarations of Compliance, customer compliance questionnaires, regulatory dossiers, and technical supporting documents. • Evaluate supplier declarations, test reports, and compliance evidence to verify material suitability. • Plan and manage migration testing programmes in coordination with accredited laboratories. • Support product qualification, material change assessment, and regulatory review of new or revised formulations and specifications. • Provide accurate and timely regulatory guidance to customers, suppliers, and internal functions. Quality Systems and Audit Management • Maintain and continuously improve the ISO 9001 Quality Management System, FSSC 22000 Food Safety Management System, and ISO 13485 Medical Device Quality Management System, where applicable. • Develop, review, and control SOPs, work instructions, forms, and related quality documentation. • Ensure robust document control, version management, and record retention practices. • Plan and conduct internal audits in accordance with the annual audit programme. • Support certification, surveillance, customer, and supplier audits. • Lead regulatory, product safety, and compliance audits as required. • Track audit findings, ensure root cause analysis is completed, and drive timely closure of corrective actions. Risk Management and Continuous Improvement • Conduct regulatory risk assessments, compliance gap analyses, and investigations into nonconformities or customer complaints. • Lead CAPA activities using structured problem-solving tools such as 8D, 5-Why, Fishbone Diagram, and FMEA. • Drive cross-functional improvement initiatives to strengthen compliance, quality performance, and operational consistency. • Act as the primary interface for customer and supplier compliance matters. • Establish and maintain supplier compliance monitoring and qualification processes. • Deliver regulatory and food-contact compliance training to internal stakeholders. • Coach QA team members and support cross-functional teams on regulatory and quality matters. • Lead or support special projects related to compliance, audit readiness, or business improvement. Requirements Education • Bachelor’s degree in Food Science, Chemistry, Chemical Engineering, Materials Engineering, Packaging Technology, Quality Management, or a related discipline. Experience • Minimum 5 years of relevant experience in regulatory affairs, food-contact packaging compliance, quality systems, or a related manufacturing environment. • Experience in metal packaging, coatings, inks, adhesives, laminates, flexible packaging, or food packaging is preferred. • Experience supporting multinational food, beverage, healthcare, or medical-device customers is an advantage. Professional Certifications • ISO 9001 Internal Auditor. • FSSC 22000 Internal Auditor. • ISO 13485 Internal Auditor preferred. • ASQ Certified Quality Engineer (CQE) or equivalent preferred. • Lead Auditor qualification advantageous. Technical Knowledge Strong working knowledge of: • Global food-contact material regulatory requirements. • FDA 21 CFR, EU, China GB, UK, and Swiss food contact material regulations. • Migration testing and Declaration of Compliance requirements. • Product safety and GMP requirements. • ISO 9001, FSSC 22000, and ISO 13485 management systems. • CAPA, FMEA, risk management, root cause analysis, and audit management.