Quality Assurance Specialist / Regulatory Affairs Specialist

Role DescriptionWe are looking for a Quality Assurance Specialist / Regulatory Affairs Specialist to support quality management, compliance, documentation, testing, and regulatory activities. This role involves ensuring products, processes, and documentation meet established quality requirements and applicable regulatory standards.The Quality Assurance Specialist will support quality control procedures, inspections, audits, corrective and preventive actions, process reviews, and quality documentation. You will analyze quality data, investigate issues, support root cause analysis, and contribute to initiatives that improve product and process consistency.The Regulatory Affairs Specialist will assist with regulatory submissions, documentation, compliance monitoring, product registrations, and communication with relevant regulatory stakeholders. You will maintain regulatory records and support teams in understanding applicable requirements.QualificationsBachelor’s degree or diploma in Quality Management, Life Sciences, Engineering, Regulatory Affairs, Pharmacy, or a related field.Strong understanding of quality assurance, quality management systems, and regulatory principles.Knowledge of audits, inspections, CAPA, root cause analysis, and quality documentation.Understanding of regulatory submissions, product compliance, and applicable standards.Familiarity with ISO standards, GMP, or other relevant quality and regulatory frameworks.Ability to review technical documents, procedures, specifications, and compliance records.Strong analytical and problem-solving skills.Excellent attention to detail and documentation accuracy.Ability to maintain organized quality and regulatory records.Good communication and collaboration skills with technical and cross-functional teams.Ability to support audits, investigations, and regulatory activities.Proactive mindset with an interest in quality improvement, regulatory compliance, risk management, and continuous improvement.