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.