Regulatory Affairs Specialist

4 days ago

Cairo, Cairo, Egypt Kemet Medical Full time 40,000 - 80,000 per year

Company Description

Kemet Medical, a 40-year-old medical equipment company, is dedicated to providing innovative, high-quality healthcare technologies combined with exceptional customer service to empower caregivers in enhancing patient lives. Over the years, we have grown from a small team of 10 employees to a thriving organization of over 150 team members, continually expanding. Serving diverse medical fields across Egypt, we offer products ranging from Radiology, ICU, OR, ER, NICU, PICU, and CCU to Laboratory equipment, infrastructure planning, consumables, and patient safety. At Kemet Medical, we remain deeply committed to creating outstanding experiences for both our customers and patients while fostering a supportive and dynamic workplace for our team.

Role Description

This is a full-time, on-site position based in Cairo for a Regulatory Affairs Specialist. In this role, you will be responsible for preparing, submitting, and managing regulatory documents to ensure compliance with applicable regulations. You will maintain a thorough understanding of regulatory requirements, communicate with relevant regulatory authorities and stakeholders, and monitor changes in regulations that could impact company operations. Additionally, the role may involve providing regulatory guidance during product development, ensuring proper documentation, and supporting internal audits and inspections.

Qualifications

  • Thorough knowledge of regulatory requirements, compliance processes, and documentation related to medical equipment.
  • Strong background in managing submissions, approvals, and communication with regulatory authorities.
  • Excellent analytical, research, and organizational skills to monitor and understand evolving regulations and implement necessary process changes.
  • Proficiency in documentation, report writing, and ensuring clarity and accuracy in written communications.
  • Exceptional attention to detail, problem-solving abilities, and the ability to manage multiple projects simultaneously.
  • Proficient in using relevant computer software, databases, and tools for regulatory processes.
  • Bachelor's degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field; advanced qualifications are an asset.
  • Prior experience in regulatory affairs in the medical equipment or healthcare industry is highly desirable.

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