Sara Zahmatkesh Email & Phone Number

• Over 8 years of experience in Regulatory Affairs and Quality Assurance roles.• Qualified to performed and maintained Quality Management System (QMS) activities: Change Control, Internal and External Audit, Audit findings, CAPA, Deviation.• Participated and supported during regulatory Inspections by: Health Canada, FDA, Notified bodies and ISO.• Performed New Product Submissions: Prepare and submit regulatory applications for new medical devices to Health Canada, ensuring compliance with all applicable regulations and guidelines.• Reviewed the Marketing Material to ensure alignment with Health Canada approvals and regulations. Establishment License Maintenance: Maintain the establishment license and other licenses to ensure adherence to regulatory requirements.• Complaint Handling and Reporting: Manage complaints related to medical devices and submit the necessary reports to Health Canada or the other regulatory authorities as required by regulations.• Ensure all registered product adheres to relevant regulations, guidelines, and industry standards, such as Health Canada, FDA, and other international regulatory bodies.• Great experience on reviewing and writing Standard Operating Procedure (SOP). • Reviewed and finalized the Quality Agreement. • Qualified/Re-qualified and Evaluated Vendors.• Experienced in data analysis, reviewed technical documents such as OOS/OOT, observations, and root cause analysis.• Excellent knowledge of pharmaceutical regulations GMP, GLP, GDP, ALCOA. • Hands on experience working with different pharmaceutical instruments like HPLC, GC, UV, FT-IR, TLC, Dissolution, Karl Fischer and performed ID, Assay, Content uniformity, Blend Uniformity and Impurity by HPLC.• Experience in microbiology labs with practical knowledge of microbial enumeration, able to isolate and identify pathogens from raw material, finished products, water samples and environmental surfaces. • Calibration of Laboratory instruments.• Through knowledge of MS Office (Microsoft Word, Excel and Power point), Foxit, Track Wise Digital (TWD), working knowledge in Empower 2, Chemstation, Intake and LIMS.• Knowledge of Method validation and stability study using related protocols in pharmaceutical company following ICH guide line.

Listed skills include Uv/Vis Spectroscopy, Adobe Acrobat, Twd, Windows, and 28 others.