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.