Radu Vornicu
Senior Manager @Parexel
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WORK HISTORY
Senior Manager @Parexel
Bucharest, RO
Management of a team of regulatory professionals, ranging from associates to senior consultants with oversight of project utilization, training compliance.Coaching and mentoring direct reports through career development.Organize resources, workload and prioritization for regional/local projects.Provides strategic and technical advice to clients on development and regulatory strategies for Medical Devices, IVDs and combination products (drug-device).Part of a digital health project team working on a monitoring program (medication reminder, allergies support) in EU and other countries.Authoring training modules for best practices in Regulatory Technical Assessment related to connected health apps and devices.Act as Project Lead for complex international projects for a major client.Coordinates with other disciplines in providing advice and strategies for regulatory submissions with the goal.of anticipating regulatory challenges and leveraging PAREXEL’s multidisciplinary expertiseSpecialized expertise in Digital Health Technology, Emergency Airway Management Products, Anesthesia Product and Class I, II, Medical Devices.Gap analysis for EU with medical device and companion diagnostic component, including regulatory strategy in the EU.
EDUCATION
Technical University of Civil Engineering
Bachelor of Science (BS)
The University of Economic Studies
Master's Degree in Business Communication (Summa Cum Laude) MA Marketing & PR
ABOUT RADU VORNICU
As a solution-focused regulatory affairs specialist with superior expertise in spearheading medical device regulations, reviews, and evaluations across 70+ countries, I have vast experience building international profitable businesses in the medical industry and Class 1, 2 3 medical devices in Switzerland, Romania, and the US. I have a comprehensive background in creating the vision, identifying opportunities, and expanding business on the international market along with providing strategic alliances and business opportunities that enabled the launching of new medical devices on U.S. soil. Additionally, I’m experienced in supporting local and international regulatory submission teams on all international product registration requirements. I’ve been repeatedly recognized for my continuous knowledge acquisition in addition to staying up to date with emerging technologies and complex global product registration requirements. Key Achievements: • Led the development and implementation of a new company-wide project management tool, which facilitated an improvement in communication, traceability, and efficiency by 15% within 12 months • Utilized expertise in initiating a new business tender, which saw the company winning the tender and increasing international sales by 20% per year with a projected increase of 100% over 4 years • Singlehandedly developed new opportunities that enabled the shift and expand from manufacturing respiratory and anesthesia products to hi-tech class 2 medical devices • Consistently coordinated the recall procedures for US, EU, Canada, and Worldwide FSCA, FSN while coordinating the FDA UDI labeling procedures and registration process in about 80 countries • Expertly assessed and provided feedback on regulatory impact of process improvements and cost saving strategies, which successfully saved costs by 15%
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