Heba Ahmed
Dubai,United Arab Emirates
Summary
Highly accomplished Regulatory Affairs professional with a strong track record of leadership in the medical device industry, particularly in In Vitro Diagnostics (IVDs). Currently leading the Administration of IVD Listing at the Egyptian Drug Authority (EDA), with validated expertise in IVD dossier evaluation, regulatory compliance, and market authorization. Well-versed in regional and international IVD regulations and guidelines, with a demonstrated ability to resolve complex regulatory challenges and implement innovative solutions. Known for fostering high-performing teams built on trust, integrity, and transparency. Licensed pharmacist holding a Bachelor of Pharmaceutical Sciences, graduating with excellence and Class of Honour.
Overview
17
17
years of professional experience
2018
2018
years of post-secondary education
1
1
Certification
Work history
Manager of Administration of IVD Listing
Egyptian Drug Authority
Cairo
11.2022 - 07.2025
- Spearhead the strategic oversight and operational management of the IVD listing administration, a critical function for medical device market authorization in Egypt.
- Lead the initiative to troubleshoot and present new concepts and ideas to optimize regulatory processes for IVDs, enhancing departmental efficiency and compliance.
- Cultivate and lead a specialized team, fostering an environment of trust, integrity, and transparency to achieve regulatory objectives.
Manager of Imported IVD Listing Unit, Administration of IVD Listing
Egyptian Drug Authority
Cairo
10.2021 - 10.2022
- Achieved timely market availability by directing the review of accepted IVDs registration applications, directly facilitating product access.
- Ensured stringent compliance and quality through comprehensive assessment of submitted IVDs technical files, critical for market authorization.
- Issued IVD market authorization licenses, contributing to the efficient introduction of essential diagnostic products.
Senior Regulatory Affairs Specialist
Egyptian Drug Authority
Cairo
04.2021 - 09.2021
- Accelerated initial approvals by receiving and processing IVDs import approval applications for marketing, contributing to faster product entry.
- Enhanced team capabilities by developing and delivering training to new employees on IVDs classification & certification.
- Managed the review and issuance of final annual approvals for IVDs, ensuring continuous regulatory compliance.
Regulatory Affairs Specialist
Egyptian Drug Authority
Cairo
11.2020 - 04.2021
- Reviewed and issued approvals for the release of imported medical devices, ensuring compliance with national regulations.
- Validated medical device registration certificates, maintaining regulatory integrity.
Regulatory Affairs Specialist
Central Administration of Pharmaceutical Affairs (CAPA), Ministry of Health
Cairo
04.2010 - 10.2020
- Managed the meticulous review of diverse documentation, including invoices, distribution/agency agreements, catalogs, and declarations certificates, for comprehensive regulatory assessment.
- Facilitated international compliance by contacting European Notified Bodies & FDA for verification of ISO, CE, & FDA certificates, demonstrating strong international regulatory understanding.
- Orchestrated scientific committee reviews by preparing detailed studies & sheets for sterile medical device accessory products or medical devices with new mechanisms, followed by organizing & executing scientific specialized committees for file review and approval.
- Reviewed medical device registration certificates (specifically for sterile medical devices) and issued approvals for releasing imported medical devices.
Pharmacist in charge
AL Osman pharmacy
Cairo
01.2009 - 03.2010
- Managed team schedules ensuring continuous provision of services.
- Managed efficient dispensing of prescription drugs for improved patient service.
- Updated knowledge on latest pharmaceutical developments to provide cutting-edge treatments.
- Streamlined pharmacy operations, enhanced efficiency in prescription handling.
Trainee Pharmacist
Al Fatah pharmacy
Cairo
09.2008 - 12.2008
- Dealt swiftly with queries from healthcare professionals and patients for prompt service delivery.
- Ensured safe storage of all drugs to maintain their efficacy.
- Adhered strictly to pharmacy laws and regulations, ensuring legal compliance at all times.
- Improved patient understanding with clear explanations about medication uses, side effects and interactions.
Education
Bachelor of Pharmaceutical Sciences -
College of Pharmacy, Cairo University
Egypt 04.2001 - /2008
Licensed Pharmacist -
MOH
UAESkills
- IVD Medical Devices Classification & Certification
- IVDR
- Medical Devices Regulations
- MDR
- Dossier Review/Assessment
- Market Authorization
- Regulatory Affairs Knowledge
- Compliance
- Leadership Skills
- Decision Making
- Problem Solving
- Effective Time Management
- Self-motivation
- Ability to Work Under Pressure
- Communication
- Communication Skills
- Teamwork
- Oral Communication
- Critical Thinking
- Accuracy
- Attention to Detail
- Ability to Multitask
- Adaptability
- Continual Learning
- Computer Skills (Microsoft Excel, Microsoft Office, Microsoft PowerPoint)
- Time management mastery
- Advanced scheduling techniques
- Resource allocation efficiency
- Performance monitoring competency
- Leadership proficiency
- Communication expertise
- Risk management aptitude
- Quality assurance techniques
- Technical writing
- Staff management
- Administrative project management
Languages
Arabic
Fluent
English
Advanced
German
Elementary
Personal Information
Nationality: Egyptian
Certification
· MOH Certificate | September 2017
Objective
Seeking a challenging senior Regulatory Affairs position within a medical device manufacturing company to leverage extensive expertise in In Vitro Diagnostic (IVD) and medical device regulations, market authorization processes, and technical dossier assessment. Committed to driving global product compliance, accelerating market access, and supporting successful product launches. Eager to contribute proven leadership, strategic insight, and problem-solving skills in a dynamic and professional environment.
Timeline
Manager of Administration of IVD Listing
Egyptian Drug Authority
11.2022 - 07.2025
Manager of Imported IVD Listing Unit, Administration of IVD Listing
Egyptian Drug Authority
10.2021 - 10.2022
Senior Regulatory Affairs Specialist
Egyptian Drug Authority
04.2021 - 09.2021
Regulatory Affairs Specialist
Egyptian Drug Authority
11.2020 - 04.2021
Regulatory Affairs Specialist
Central Administration of Pharmaceutical Affairs (CAPA), Ministry of Health
04.2010 - 10.2020
Pharmacist in charge
AL Osman pharmacy
01.2009 - 03.2010
Trainee Pharmacist
Al Fatah pharmacy
09.2008 - 12.2008
Bachelor of Pharmaceutical Sciences -
College of Pharmacy, Cairo University
04.2001 - /2008
Licensed Pharmacist -
MOH
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