Summary
Overview
Work history
Education
Skills
Languages
Custom
Personal Information
Certification
Timeline
Generic

Abdullah Hani

Jeddah,Saudi Arabia

Summary

Experienced Regulatory and Quality Manager with a 12-year tenure in a Medical Devices company, adept at ensuring compliance with SFDA regulations. Skilled in formulating and enforcing compliance policies compliant with current legislation, and steadfast in upholding the highest ethical and regulatory standards.

Overview

17
17
years of professional experience
1
1
Certification

Work history

Regulatory Affairs and Quality Assurance Manager

Al Nozha Medical Co. (W.L.L)
Jeddah, Saudi Arabia
01.2011 - Current

SFDA Regulatory Compliance: Deep expertise in SFDA regulations for medical devices.

Product Registration: Proficient in SFDA product registration, ensuring accuracy and timeliness.

Compliance Management: Vigilant in overseeing product and practice compliance with local standards.

SFDA Liaison: Effective communicator with SFDA, managing regulatory interactions.

Documentation Management: Oversaw accurate and compliant regulatory documentation.

Market Surveillance: Stayed current with changes in regulatory legislation.

QMS Maintenance and Internal Audits: Maintained the company's QMS, ensuring continuous compliance and efficiency. Conducted thorough internal audits, identifying areas for improvement.

Management Representative: Served as the primary management representative in quality matters, liaising between management and regulatory bodies.

Regulatory Affairs Supervisor

Saudi Arabian Drug Store Ltd.
Jeddah, Saudi Arabia
01.2009 - 02.2010

SFDA Compliance Assurance: Diligently ensured adherence to all SFDA regulatory standards and guidelines.

Recall Management

Pharmacist

United pharmacy
Jeddah, Saudi Arabia
01.2007 - 08.2007
  • Dispense medications following prescriptions issued by an authorized medical practitioner
  • Inventories, orders, and maintains supply of drugs, chemicals, and other pharmaceutical stock

Education

Professional Training - Regulatory Affairs of Drugs and Medical Devices

Philadelphia University
Online, Amman

Diploma - Marketing Communication

London College of International Business Studies (LCIBS)
London, The UK

BSc - Pharmacy

Jordan University of Science & Technology (JUST)
Irbid, Jordan

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Post Graduate Diploma in Regulatory Affairs - Medical Devices as major

Institute of Good Manufacturing Practices India (IGMPI)
Online, India

Skills

  • Medical Devices regulations knowledge
  • Compliance monitoring
  • Quality Management System (QMS) Oversight
  • Internal Audit Management and Leadership
  • Quality Management Representative
  • Continuous Quality Improvement


Languages

Arabic (Mother-Tongue)
English (Excellent)

Custom

  • Problem Solving & Decision Making
  • Presentation and Communication Skills
  • Internal Quality Auditing Training Course, 04/02/17
  • Pharmaceutical Marketing skills & Dealing with Customers
  • Decision Making, Problem Solving & Creative thinking & Communication Skills Workshop

Personal Information

  • Date of birth: 01/12/84
  • Nationality: Syrian

Certification

Certified Internal Auditor for Quality Management System (ISO 9001:2015) - TÜV Middle East, Riyadh, Saudi Arabia, January 2024 (Certificate No. QMS/01/2024/1510)

Timeline

Regulatory Affairs and Quality Assurance Manager

Al Nozha Medical Co. (W.L.L)
01.2011 - Current

Regulatory Affairs Supervisor

Saudi Arabian Drug Store Ltd.
01.2009 - 02.2010

Pharmacist

United pharmacy
01.2007 - 08.2007

Professional Training - Regulatory Affairs of Drugs and Medical Devices

Philadelphia University

Diploma - Marketing Communication

London College of International Business Studies (LCIBS)

BSc - Pharmacy

Jordan University of Science & Technology (JUST)

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Post Graduate Diploma in Regulatory Affairs - Medical Devices as major

Institute of Good Manufacturing Practices India (IGMPI)
Abdullah Hani