Senior Regulatory Compliance Engineer / Assistant Manager

Key Responsibilities

• 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.

• 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.

• 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

• Bachelor’s degree in Food Science, Chemistry, Chemical Engineering, Materials Engineering, Packaging Technology, Quality Management, or a related discipline.

• 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.

• 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.