Niloofar Niknazar Email & Phone Number

Greater Toronto Area, Canada

Toronto, Ontario, Canada

Data Analyst:A- Use excel to analyze device and spare parts prices and create a reportB- Visualize the result of data analysis with Power BI and create a monthly presentationRegulatory Affairs: A- Health Canada Submissions: Gather, prepare and coordinate the technical documents for regulatory submissions such as New licensing, license amendment, MDEL and MDAL license renewal, fax back, private label, Special Access Approval (SAP)B- Maintain Regulatory Status Tracker and provide reports to the Product and Business Management team. C- Review new/updated Medical Device Regulations (SOR /98-282) and list applicable action items accordingly (i.e., Foreign Risk Notification (FRN), MDSAP, Summary reports, and issue-related analyses of safety and effectiveness for medical devices)D- Regulatory SOPs: Assist in updating regulatory SOPs according to Canadian regulations and corporate policies. E- Marketing Communication Compliance: Review Marketing materials (IFU, labels, brochures, webinar content) before releasing them for tradeshows, social media, Labeling, and Email communication through Marketo Software. Quality Assurance: A. Quality Assurance KPIs Tracking: update and maintain critical quality KPIs status such as numbers of complaints, Recalls, Field Services, Mandatory Reports, Out of Box failures, Released Change Assessment documents and etc. B. Audit: assist in performing internal and external audits such as Health Canada, ISO 9001, MDSAP, QMS, and Security audits. C. Review and update Business Process: review and update business processes (SOPs), Work Instruction (WI), and current policies to optimize and automate current workflowD. Complaint handling: Investigate, fill and report complaints to First and Second level service team to resolve Quality issues. E. Training Record: Review and update the training matrix and training records.

Esfahan, Iran

● CRM: update sales records (Quote, Discount approvals, …)● Power BI and Excel: Preparing, cleaning, and sorting the data for periodic organizational reports ● Reporting: Creating and visualizing the reports with Tableau for stakeholders● Project coordination: Assist in the coordination of various aspects of the day-to-day operations of the organization such as maintenance of business records/files, contracts management, and policy development and fulfillment.

Esfahan, Iran

● SAP: Provide ongoing administrative support to project teams (i.e, Purchase Order Requisition) ● Producing and coordinating reports using Excel● Assisting with the preparation of presentations and pitches for prospective clients

Master Of Science, Industrial Engineering

Courses: Advance Data Mining ( R, Python, SQL) Text Mining and Numerical Analysis Advance Statistical Methods ( Clustering, Advance.

Master Of Science - Ms, International Business

Bachelor'S Degree, Business Management