Moamar Mustafa

About Moamar Mustafa

Global regulatory affairs | director of global certifications | lab & site operations…

Experience

1. Sr Manager Compliance Safety Lab Operations & Certifications

   Philips

   Jan 2018 — Present · Pittsburgh, PA, US

   Lab Operations Management, Responsible for the performance of Compliance Safety & EMC Lab testing & evaluation of a variety of Medical products to the provisions of USA, Canadian and other International safety standards (e.g. IEC/ANSI /AAMI / CSA 60601-1, and IEC 60•••12 and Collateral and Particular standards).• Experience interacting with regulatory agencies and participating in audits.• Manage day-to-day lab Operations & Project Management to ensure on time submission to FDA 510K & Manufacturing Launch.• Manage $7 Million Capital Equipment and Lab budget • Review emerging regulations and changing standards for potential impact to business. Propose compliance plans to meet changing requirements.• Interface and participate in site audit/inspections from outside agencies such as FDA to ISO 13485, and certification agencies, and Notified bodies such as TUV, Intertek & UL.• Act as liaison with external testing & certification bodies to assure accurate and cost-effective test strategies are implemented in a timely manner and documented in accordance with applicable global standards.• Assist product development and manufacturing to maintain proper testing & product configuration data to demonstrate continued compliance.• Participate in Business Strategy for Global Market access working with the Regulatory Team, the Business Development directors and Sales team to achieve company\'s target of Market Share.• Collaborate & Participate & work with the Regulatory Affairs group to provide the needed reports to comply with the FDA Guidance & 510K approval.• Collaborated with the Regulatory team to obtain 510K Approvals & obtain Certificates of Compliance to International Markets, such as Brazil, China, Japan, Korea and EU.

Education

• The University of Akron

  Bachelor of Science

  1990 — 1996

• Keller Graduate School of Management of DeVry University

  Master Degree: MBA

  2012 — 2015

Skills

• Program Management
• Electronics
• Middle East Govt. Regulations-Conformity Assessment
• Project Planning
• Team Leadership
• Gas
• Quality Assurance
• Quality Control
• Operations Management
• 5s
• Iso 13485
• Technology Needs Analysis
• Team Building
• Management
• Inspection
• Quality Management
• Process Improvements--Operations
• Continuous Improvement
• Compliance
• Manufacturing
• Six Sigma
• Compliance & Standards Requirements
• Process Improvement
• Middle East
• Leadership
• Management Consulting
• Budgets
• Process Engineering
• Product Development
• Troubleshooting
• Iso
• Fda
• Project Management
• Risk Management
• Quality System
• Spc
• Change Management
• Root Cause Analysis
• Electricians
• Logistics