Job Purpose

The Regulatory Affairs Manager is responsible for ensuring regulatory compliance and product registrations for all medical devices manufactured by the company, managing interactions with regulatory authorities, and supporting market access locally and internationally while maintaining alignment with ISO 13485 and applicable regulations.

Key Responsibilities

1) Regulatory Strategy & Compliance

• Develop and implement the regulatory strategy for:
  • Local market (Egypt)
  • Export markets (EU, GCC, Africa, MENA)
• Ensure compliance with:
  • Egyptian Drug Authority (EDA) / MOH
  • NFSA (where products are classified as supplements or special dietary foods)
  • ISO 13485
  • EU MDR 2017/745 (if applicable)
• Monitor regulatory changes and assess impact on existing and new products.

2) Product Registration & Licensing

• Prepare, submit, and maintain:
  • Medical device registration dossiers
  • Establishment licenses
  • Product renewals and variations
• Manage:
  • Technical Files / STED
  • Declarations of Conformity
  • Labeling and IFU compliance
• Ensure timely renewals and lifecycle maintenance.

3) Regulatory Authority Liaison

• Act as the primary contact with:
  • Egyptian Drug Authority (EDA)
  • Ministry of Health (MOH)
  • NFSA
  • Certification bodies and notified bodies
• Coordinate responses to:
  • Deficiency letters
  • Regulatory questions
  • Inspection findings

4) Change Control & Regulatory Impact

• Evaluate regulatory impact of:
  • Raw material changes
  • Supplier changes
  • Manufacturing process changes
  • Labeling or claims updates
• Ensure regulatory approvals are obtained before implementation.
• Maintain change history and approval records.

5) Labeling, Claims & Advertising Compliance

• Review and approve:
  • Product labels
  • IFUs
  • Marketing and promotional materials
• Ensure compliance with:
  • Approved claims
  • Language requirements (Arabic / English)
  • Local and export market rules
• Prevent unapproved medical or therapeutic claims.

6) Audit & Inspection Support

• Support:
  • Regulatory inspections
  • MOH / EDA factory inspections
  • ISO and notified body audits
• Ensure availability and readiness of:
  • Regulatory documentation
  • Licenses and approvals
• Coordinate corrective actions for regulatory findings.

7) Post-Market Surveillance (PMS) & Vigilance

• Establish and maintain:
  • PMS systems
  • Complaint handling procedures
  • Vigilance reporting (adverse events, recalls)
• Coordinate with QA and Quality Manager on:
  • Field actions
  • Trend analysis
  • Regulatory reporting timelines

8) Cross-Functional Coordination

• Work closely with:
  • Quality Assurance
  • R&D / Product Development
  • Production
  • Marketing & Sales
• Provide regulatory guidance during:
  • New product development
  • Technology transfer
  • Market expansion projects