Heba Kamal

Led MDR submissions and technical file writing/updates, including EUDAMED legacy device migration and PRRC/QMS activities. Served as class IIa/III liaison for pharmacovigilance and materiovigilance, supporting PMS and compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, ISO 11135, MDR 2017/745, and FDA QMSR.

Managed regulatory compliance for global markets for Class I medical devices and OTC drugs by maintaining and updating regulatory dossiers and strategies. Coordinated change controls, performed impact and risk assessments, and managed RIM software and supplier compliance.

Owned regulatory compliance for international markets by integrating RIM software and authoring work instructions/SOPs to streamline processes. Prepared and managed regulatory submissions, risk assessments, and documentation for international market entry.

Led regulatory strategy and international registrations across APAC and MENA and managed US 510(k) submissions. Oversaw license maintenance/renewals, post-approval changes, and non-compliance corrections for the infection prevention portfolio while coordinating across Quality, PV, R&D, Marketing, and Business.

Performed regulatory intelligence and analyzed new market regulations to support international regulatory strategies. Prepared registration files and coordinated with local agents/subsidiaries, including drafting responses to health authority inquiries and managing priorities.

Served as the focal point for export-related activities, including writing and maintaining SOPs for local activities. Prepared and maintained regulatory files in collaboration with local agents and managed labeling updates for all drugs within the Egyptian subsidiary.

Delivered GCC-focused regulatory program management, including eCTD management responsibilities and regulatory project coordination. Supported submission-oriented documentation workflows using regulatory IT tools.

Provided GCC region regulatory specialist support, focused on submission and documentation activities within regulatory workflows. Contributed to implementation and use of regulatory IT tools such as RIM/ERP and related documentation systems.

Worked as an intern evaluator in the registration department supporting review-related activities for regulatory documentation. Assisted within the registration process under supervision.

Completed a Master’s (MSc) in Health Engineering with a focus on Technical Regulatory Affairs. Earned education aligned to international health regulatory and technical dossier needs.

Completed a Management Diploma in Lyon to complement regulatory training with business and management education.

Completed a University Diploma program in French as a Foreign Language (French language and university integration).

Earned a Pharmacist Degree at the Faculty of Pharmacy and Biotechnology of the German University in Cairo. Completed professional pharmacy education over five years.