RADA TRIFONOV

Regulatory Affairs Professional with eight years of experience in international regulations across various fields, compliance, submissions, and technical writing. Demonstrated leadership in guiding teams and projects to successful outcomes, recognized by industry experts. Committed to excellence with a detail-oriented approach, fostering both individual growth and team success. Strong capability for effective self-learning and project managment.

• Effectively managed a project team, accelerating the submission of technical files to European, American, Canadian, and Israeli health agencies within a stringent deadline.
• Composed significant post-marketing, clinical, and biological evaluation reports, all of which were successfully accepted in professional reviews with only minor modifications required.
• Collaborated with the QA department to successfully pass the MDSAP, MDR, and ISO 13485 audits with minimal non-conformities.
• Successfully completed the launch of a new Diode Laser device project ahead of schedule and $50,000 below the projected budget.
• Documented and resolved change control issues by creating a Change Reporting Assessment Form which led to ease of changes review and submission to authorities.
• Implemented a Change Reporting Assessment process to document and manage change control issues effectively, enhancing the review process and risk management resulting in streamlined reviews of changes and simplified submission processes to authorities.

• Israeli Security Agency