Mahjabeen Waris

Experience

1. Associate Regulatory Consultant

   Mrc Global

   Feb 2022 — Present

   Create, edit, review, and maintain regulatory submissions to support country specific marketing approval e.g, EU MDR technical documentation, 510(k), Health Canada License Application.• Author, review, and finalize EU regulatory documents including clinical evaluation plans and reports (CEP & CER), summary of safety and clinical performance (SSCP), and post-market follow-up plans and reports (PMCF).• Perform systematic literature and data reviews for medical devices.• Prepare, review, and submit regulatory documentation to the FDA for new products and product changes to ensure timely approval for market release in accordance with all applicable regulations, standards, and guidance.• Coordinate and facilitate cross-functional document planning through collaboration between different departments.• Update European/international technical documents as needed when there are changes to products, testing, manufacturing claims, or labeling.Review product labeling including advertising and promotional materials for compliance with regulatory approvals.