Regulatory Affairs
Medtronic
Total years of experience :17 years, 7 Months
• Main duties include: Support tenders’ submission by providing required certificates and statements as applicable.
• Coordinate and monitor Regulatory PMS activities including Vigilance reporting and Field Action within the MENA region.
• Perform and overview the field action administration activities and reporting including customers’ notifications, products recall, and competent authorities notification.
• Generate status reports on MENA regarding field action progress to RAE and BU.
• Track regulatory project status and informational documents appropriately.
• Assist in developing, implementing and monitoring internal operating systems and procedures.
• Prepare international regulatory body submissions for new products and product changes as required to ensure compliance with countries’ specific regulations.
• Maintain Document Center databases for document tracking, distribution and purging and reporting..
• Assist in regular daily certificate / regulatory request received from other department
• Main duties include: Performing the Supply Chain Management Cycle, from price negotiation and procurement from Worldwide Suppliers until delivery to the customer, going through all the logistics procedures and related paperwork (Submit orders to suppliers, LC applications, Communication with freight forwarders, clearance agents, Customer Support Unit…)
• Prepare relevant reports in terms of sales per segment, per brand, and per sales person and submit to management for curative action.
• Follow up with the Governmental Bodies ( Ministry of Health, Lebanese Atomic Energy Commission …) for products’ registration and capital equipment import procedures.
• Appointed as project coordinator for the implementation and application of the CRM (Customers Relationship Management) program within the company.
• Appointed as Internal Quality Auditor to follow up and coordinate the implementation and maintenance of the ISO 9001:2008 Quality Management System in the company.
• Local Purchases for Office’s Electronics.
• Contribution in the preparation of congresses and workshops.
• Contribution in the recruitment of Junior Logistics Officers for the department, by handling the 2nd interview process and selecting potential candidates for final interview with the management.
• Continuous endeavor to reach the best Quality/Price ratio when it comes to existing suppliers and identifying new brands for distributorship.
• Main duties include: invoicing, purchasing, procurement, maintaining an up to date customers database, travel arrangements, reports writing, collecting outstanding invoices, preparing payrolls and expenses reports.
• Achieved a sheet of the Oracle University Courses, and a marketing oriented strategy for potential customers, as well as a pipeline of the company’s services and customers’ list.
• Being one of the only 7,000 Regulatory Affairs Professionals worldwide accredited by RAPS (one of the only 2 major international professional membership societies for RA accreditation) • Courses emphasis on 4 Core Courses: Ethics, Global Regulatory Strategy for Medical Devices, Medical Devices (MD): Definition & Lifecycle, Role of the RA Professional; and 5 Elective Courses: Introduction to Global Healthcare Product Regulations, MD: Compliance & Audits, MD: EU Regulations, MD: US Regulations, Quality System Regulations (QSR).
• Being accepted as one of the 90 persons selected from all over the world to attend this course. • Courses emphasis on: Business Strategy, International Growth and Business Plan.
• Graduated top of the class with an average of 94 / 100. • Courses emphasis on International Trade, Global Transportation & Logistics.
• First Of Promotion with an average of 17.00/20.00. • Courses emphasis on Microbiology, Immunology, Hematology, Analytical Chemistry, Biochemistry, Biophysics with corresponding applied methods & Lab Techniques