EZGI GULCICEGI

Dedicated and results-oriented professional with two years of experience in Bio-Medical Device Sales and technical support. Currently pursuing a Postgraduate Diploma in Medical Device and Technology at Griffith College Dublin to deepen understanding and expertise in the chosen field. Skilled in customer service, sales, technical support, and biomedical engineering. Proficient in MATLAB, Python, and Java. Strong attention to detail, time management, and problem-solving abilities. A quick learner with a proven track record of meeting and exceeding goals. Passionate about contributing to the healthcare industry through innovative technology and solutions. Experience in customer service as a Deli Assistant. A hardworking and dedicated Regulatory Affairs Specialist is successful at preparing and documenting regulatory paperwork. Tireless in maintaining a current understanding of legal regulations in order to keep all products compliant. Bringing 4 years of biomedical experience and seeking a growth-oriented position. Highly motivated employee with a desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

• Responsible Manager Certificate, TCSIS
• Sales Promotional Certificate(TCSIS
• Clinical Support Certificate(TCSIS
• Teacher Training Certificate, Demokrasi University

• Extensive experience in Regulatory Affairs for IVD device submissions in the context of drug/biologic submissions, including EU COMBINE and IVDR Technical Documentation dossiers.
• Strong understanding of IVD directives, regulations, and structures, including economic operator and personnel roles, notified bodies, competent authorities, and mutual recognition agreements (MRAs) within the United Kingdom, Northern Ireland, and the European Union.
• Proficient in regulatory strategy, writing, submission, and authority interactions.
• Skilled in regulatory project management, ensuring timely and accurate completion of assigned projects.
• Excellent organizational, written, and verbal communication skills.
• Proficiency in Microsoft Office and project management software applications, e.g., MS Project.
• Bachelor’s degree in an applicable scientific discipline; master’s degree or higher preferred.

• Gender: Female
• Nationality: Turkish
• Visa Status: Stamp 4

• English, Fluent
• Turkish, Native

I do hereby confirm that the information given in this form is true to the best of my knowledge and belief.