Junior Regulatory Affairs Specialist

4 days ago

Giza, Giza, Egypt SURGINOVI Full time

The Role:

We are looking for a detail-oriented and motivated Junior Regulatory Affairs Specialist to join our team. In this role, you will be instrumental in the global market release of our surgical planning software platform and medical devices. You will work closely with our R&D team, software development, quality, and clinical teams to ensure our products comply with all applicable regulatory requirements from conception through to market release and post-market surveillance.

Key Responsibilities:

  • Support the preparation, compilation, and submission of regulatory filings to global authorities (FDA, CE Mark under MDR/IVDR, and other international markets).
  • Assist in the creation and maintenance of technical documentation as required by medical device regulations.
  • Collaborate with the R&D and software development teams to review and ensure that design controls, verification, and validation activities meet regulatory and quality standards.
  • Help maintain the company's Quality Management System (QMS) and ensure adherence to established procedures.
  • Conduct reviews of software documentation, including requirements specifications, architecture design, and test protocols, for regulatory compliance.
  • Support regulatory assessments for product changes and ensure all documentation is updated accordingly.
  • Stay current with evolving global regulations, standards, and guidance documents pertaining to medical device software, including SaMD (Software as a Medical Device).
  • Assist in communications with regulatory bodies and notified bodies as needed.

Required Qualifications:

  • Bachelor's degree in biomedical engineering, pharmacy, Sciences, or a related field.
  • 1-2 years of experience in a regulatory affairs, quality assurance, or related role within the medical device industry; internship experience will be considered.
  • Foundational knowledge of medical device regulations and standards, such as ISO 13485, FDA 21 CFR Part 820, and the European Medical Device Regulation (MDR).
  • Familiarity with key software-related standards, particularly IEC 62304.
  • Excellent attention to detail and strong technical writing skills.
  • Ability to manage multiple tasks and work effectively in a collaborative, cross-functional team environment.

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