Budapest Metropolitan Area
PROFESSIONAL MISSION: I am passionate about bringing reliable, evidence-based products to market and contributing to healthcare innovation through scientific rigor, regulatory excellence, and a strong commitment to quality. AS A DIETITIAN, I HAVE GAINED extensive experience: in product development; in regulatory affairs; in quality management. MY PROFESSIONAL BACKGROUND INCLUDES: the development of novel foods, dietary supplements, foods for special medical purposes, and medical devices. Since 2020, I have been working as Product Development Manager / QMS Manager at VitaPlus Ltd - Ceres Pharma Hungary Ltd. KEY ACHIVEMENTS AND RESPONSIBILITIES: • Successfully launched 4–5 new products annually, managing the entire process from product selection and market assessment to artwork development and regulatory notification/registration. • Led the implementation and ongoing maintenance of the ISO 9001:2015 Quality Management System, ensuring continuous compliance and quality improvement. • Managed regulatory documentation for medical devices, including legacy devices and MDR-compliant products. • Collaborated with international cross-functional teams to support product development, regulatory compliance, and market access activities. • Reviewed and approved marketing materials to ensure compliance with regulatory requirements and scientific accuracy.
Quality Assurance & Quality Management Systems • Led the implementation and ongoing operation of the company’s ISO 9001:2015 Quality Management System as appointed Quality Management Representative (QMR). • Responsible for the coordination and continuous maintenance of the ISO 9001:2015 QMS, including internal processes and compliance monitoring. • Conducted internal audits in accordance with ISO 13485:2016 requirements (internal auditor qualification). • Managed customer complaints and coordinated corrective and preventive actions (CAPA) as part of the quality system. Regulatory Affairs & Compliance • Managed regulatory dossiers and maintained international regulatory communications with partners and authorities. • Coordinated full notification processes, including NNGYK submissions for dietary supplements and CPNP registrations for cosmetics. • Obtained Free Sales Certificates for export markets (e.g., Vietnam, Türkiye, North Macedonia, and other countries). • Registered medical devices in the Hungarian NOR system in compliance with MDR requirements. • Reviewed multilingual product artworks for dietary supplements and medical devices, ensuring regulatory compliance and cross-market consistency (labeling, packaging text, and legal requirements). • Developed and reviewed Hungarian-language labeling and packaging texts for dietary supplements in accordance with applicable regulations. Food Supplement Development & Product Lifecycle Management • Conducted market research based on internal and external sales data. • Identified and evaluated new product concepts, including active participation in international industry exhibitions (e.g., Vitafoods). • Developed product formulations and coordinated the end-to-end product manufacturing process with internal and external stakeholders. • Led full artwork development for product packaging and labeling. • Supported product launch activities, preparing professional and consumer communication materials.
• Wrote PR articles and blog posts on nutrition and health-related topics. • Reviewed website content from a regulatory compliance perspective. • Evaluated product packaging for both professional accuracy and compliance with applicable legal regulations. • Proofread and reviewed professional materials to ensure quality and accuracy. • Provided individualized dietary counseling to private clients.
• Prepared and coordinated human clinical studies involving functional foods, including protocol synopsis development and study documentation. • Contributed to the development of functional food products, from concept generation to prototype formulation. • Ensured compliance with relevant regulatory requirements throughout product development and clinical research activities. • Managed the notification process for dietary supplements intended for the Hungarian market. • Developed educational materials and nutrition-related content for adult audiences. • Designed and evaluated dietary assessment tools, including Food Frequency Questionnaires (FFQs) and food diaries.
Provided dietary and nutrition education to school-aged children as part of the EFOP-1.8.5-17 “Cool School Canteens” project. Participated in the preparation and submission of grant applications and project proposals.