Product Compliance Assistant

Overview

The Product Compliance Assistant plays a crucial role in supporting product compliance operations by verifying that products, documentation, and associated processes align with relevant regulatory frameworks, industry standards, and internal quality guidelines throughout the product lifecycle.

Key Responsibilities

• Maintain and update compliance documentation and records diligently.
• Review and assess product documentation for adherence to regulations.
• Coordinate submissions required for regulatory approvals.
• Monitor ongoing compliance activities within product lifecycles.
• Assist with preparing and facilitating product audits and inspections.
• Collaborate across multiple departments including regulatory affairs, quality assurance, product management, engineering, manufacturing, legal, and supply chain to guarantee compliance before product release and during production phases.
• Keep abreast of evolving regulatory requirements and industry standards.
• Support risk assessment activities and help draft compliance reports.
• Manage corrective and preventive actions (CAPA) to address compliance issues.
• Contribute to continual enhancement of compliance and quality management systems.

Required Qualifications and Experience

• Possession of a Bachelor's degree or Diploma in Quality Management, Regulatory Affairs, Engineering, Business Administration, Life Sciences, Manufacturing, Information Technology, or related fields.
• Prior experience in roles related to product compliance, regulatory affairs, quality assurance, product documentation, quality control, or compliance support.
• Comprehensive understanding of compliance workflows, quality management systems, audit protocols, document control, and risk management.
• Knowledgeable about international quality standards and regulations such as ISO 9001, ISO 13485, CE Marking, RoHS, REACH, GMP, FDA, IEC norms, or comparable frameworks.
• Experienced in managing technical documentation, regulatory application coordination, document revision processes, and audit support.
• Skilled user of Microsoft Office and familiarity with document management, ERP, quality management, compliance software, or workflow systems.
• Strong analytical and organizational capabilities with a keen eye for detail to detect compliance concerns and support corrective measures.
• Effective communication skills to work closely with multidisciplinary teams spanning engineering, legal, manufacturing, suppliers, regulatory, and business units.
• Desirable experience includes supplier qualification, product certification, conducting internal audits, facilitating external inspections, and driving continuous improvement efforts.
• Additional advantage for those acquainted with Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), statistical quality controls, or project management techniques.
• Certifications such as ISO 9001 Internal Auditor, ASQ Certified Quality Improvement Associate, Certified Quality Auditor, Lean Six Sigma Green Belt or comparable credentials are beneficial.
• A motivated professional characterized by attention to detail, integrity, and dedication to regulatory compliance, product quality, and operational excellence to ensure continuous product conformity with legal and business standards.