Regulatory Affairs Specialist

2 weeks ago

Giza, Giza, Egypt Scope Medical - Egypt Full time 160,000 - 400,000 per year

Key Responsibilities

  • Prepare and submit regulatory dossiers for medical device registration and renewals.
  • Maintain and update technical documentation files (TDF), risk management files, CERs, PMS documentation, IFUs, and labeling.
  • Monitor local and global regulatory requirements and communicate updates internally.
  • Review product changes and assess regulatory impact.
  • Support audits, inspections, and CAPA-related regulatory activities.
  • Review packaging, labeling, and marketing materials for regulatory compliance.
  • Coordinate with QA, QC, Production, R&D, and external authorities.
  • Participate in vigilance activities and post-market surveillance.

Qualifications & Requirements

  • Bachelor's degree in
    Pharmacy, Biomedical Engineering, Biotechnology
    , or related field.
  • 2–5 years of experience
    in Regulatory Affairs within the
    Medical Devices
    industry.
  • Strong knowledge of
    ISO 13485, ISO 14971, MDR 2017/745
    , and EDA requirements.
  • Excellent documentation, technical writing, and communication skills.
  • High attention to detail and strong analytical abilities.
  • Ability to work independently and manage multiple submissions.

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