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Boston Scientific Senior Regulatory Affairs Specialist 
Egypt, Cairo, Cairo 
942016273

13.09.2024

As a Regulatory Affairs Specialist, you will be responsible of supporting the regulatory submission and provide input on regulatory-related issues associated with compliance and achieving the business plan for Egypt& African countries as needed.

Key Responsibilities

  • Prioritize and plan on product registration for his/her respective product lines.
  • Preparing, coordinating, and submitting regulatory applications dossiers in coordination with business partners registration, Vigilance, ..etc.
  • Maintain an active knowledge of the status of pending approvals /submissions, and shepherd registrations through the approval process.
  • Provide the management team with regular updates on product registration.
  • Ensure product registrations files are reviewed and renewed as required.
  • Supports tender operations by timely supply of accurate regulatory documents.
  • Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
  • Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.
  • Ensures to meet additional Regulatory project requirements support if assigned and when needed.
  • Attend team meetings as required.

Required Skills and Qualifications

  • Bachelors Degree in Scientific discipline/engineering preferred
  • Has the at least 2 to 3 years’ experience in Regulatory environment
  • Knowledge and experience of local regulations and standards.
  • Knowledge and experience with the Egyptian Authority different departments.
  • Must highly have organization skills / and can manage multitask in very competitive environment.