Amira Sayed

Regulatory affairs section head @ Euromed for Medical industries

About

Regulatory & Quality Lead / Senior Professional | Medical Devices Industry Regulatory Affairs and Quality professional with over 9 years of experience in the medical device industry. Proven expertise in CE Marking, ISO 13485, MDR 2017/745, and Risk Management (ISO 14971). Strong leadership background as IPC Manager ensuring in-process quality control and compliance with international standards. Experienced as a Regulatory Affairs Section Head managing CE technical files, audits, and regulatory submissions. Adept at coordinating cross- functional teams to maintain certification and improve system efficiency.

Country

Egypt

City

Cairo

Industry

Chemicals

Skill

Quality Control, Data Analysis, Good Clinical Practice (GCP), Regulatory Examinations, Clinical Research, Quality Assurance, Quality System, Quality Auditing, Due Diligence, Good Manufacturing Practice (GMP), Auditing, English, Legal Compliance, Internal Audits, Root Cause, Regulatory Requirements, Quality Management, Medical Writing, Medical Device Directive, U.S. Food and Drug Administration (FDA)