Djellza Popaj

Regulatory Affairs Biologics Specialist @Calcivis

Edinburgh, GB

Develop and implement regulatory strategies for combination products to ensure compliance with FDA requirements (both CDRH and CDER), as well as international regulations such as CE Marking and UKCA Mark.Prepare and submit PMA applications, supplements, amendments, annual reports, and updates related to post-approval commitments.Prepare and submit regulatory documentation for CE Mark and UKCA Mark certifications.Serve as the primary contact with the FDA, Notified Bodies, and UK Conformity Assessment Bodies (CABs); lead regulatory meetings and teleconferences.Conduct and manage Post-Market Surveillance (PMS) activities in alignment with regulatory requirements.

Universiteti i Prishtinës "Hasan Prishtina"

Master's degree

Friedrich Schiller University Jena

Clinical/Medical Laboratory Science/Research