Regulatory Affairs Document Control
Resume:
Hadeel Obeidat
Regulatory Affairs & Document Control Specialist
Raleigh, NC, US
**********.*******@*****.***
Professional Summary
Results-driven Regulatory Affairs and Document Control Specialist with over 10 years of experience in documentation, compliance, and quality management systems within the medical and healthcare industry. Proven expertise in ISO 13485 and 9001 standards, with a strong attention to detail and commitment to regulatory excellence.
Skills
• Quality Assurance
• Database Management
• Document Organization
• Quality Management
• Data Accuracy
• Electronic Archiving
• Compliance Controls
• Tracking Document Flow
Work Experience
Regulatory Affairs Nov 2019 – Jul 2021
BLIDA Novel Devices Co., Amman-Jordan
• Followed document control procedures in transmitting and receiving documents.
• Utilized advanced software (MS Word, Excel, Adobe Acrobat) for document processing.
• Implemented and monitored document workflow processes.
• Reviewed and edited documents for compliance and accuracy.
• Prepared regulatory documents for medical, cosmetics, and healthy food product registration.
Document Controller Feb 2016 – Oct 2019
JOY Health Care Co., Irbid-Jordan
• Handled documentation for regulatory submissions of medical and healthcare products.
• Ensured document accuracy and maintained electronic filing systems.
• Reviewed QSM, SOP, WI, and QA/QC documentation.
• Participated in ISO 13485 and ISO 9001 certification processes.
Documentation Specialist Jul 2011 – Dec 2015
AraGen Biotechnology, Sahab-Jordan
• Managed confidential documents and adhered to regulatory standards.
• Identified and addressed gaps in documentation processes.
• Authored SOPs and user manuals.
Education
B.A. in Biotechnology and Genetic Engineering
Philadelphia University, Amman – Jordan (2007 – 2010)
Training Courses
• Enterprise Risk Management
• Simplification of Work Processes and Procedures
• GS1 Bar Code Applications
Languages
• Arabic: Native
• English: Professional Working Proficiency
• Turkish: Beginner
References
Murshed Mohammad
General Manager, Joy Health Care Industry Co. Ltd & BLIDA Novel Devices Co. Ltd
Tel: +962-*********
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