Saba Sohail

Quality Assurance & Regulatory Affairs Associate @Mui Scientific

Assisted in maintaining the company’s ISO 13485 Quality Management System and regulatory compliance activities, while supporting audits, technical documentation, labeling, and product inspections to ensure both quality and regulatory requirements were consistently met.Supported maintenance of the ISO 13485 Quality Management System in compliance with EU MDR, UK MDR, Health Canada, and FDA requirements.Assisted with audits, technical file maintenance, and regulatory submissions including EUDAMED and GUDID uploads.Prepared and controlled SOPs, work instructions, training records, and change control documentation.Logged and analyzed quality events (complaints, CARs/PARs, NCRs, CCs) to drive continuous improvement.Supported labeling compliance and regulatory assessments for product design changes and modifications.Contributed to incident reporting activities and Management Review data analysis for regulatory and leadership review.Performed inspection support across incoming materials, in-process production, and final product release to ensure compliance with specifications.