Eszter Völgyi
Sr Clinical Evidence Manager @Orthofix
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WORK HISTORY
Sr Clinical Evidence Manager @Orthofix
Directing global clinical evidence and medical writing functions across all company business units, leading and developing teams of up to 10+ direct reports to support portfolio-wide clinical and regulatory needs- Leading process harmonization, vendor oversight, and budget development, ensuring operational consistency, accountability, and efficient resource allocation- Transformed a fully outsourced medical writing model into a newly established, high-performing in-house team, delivering significant gains in efficiency, quality, and cost savings- Standardized Clinical Evaluation (CER) and Post-Market Clinical Follow-Up (PMCF) procedures, templates, and processes across five North American sites and quality systems, supporting five major product franchises- Developing and optimizing international clinical regulatory processes, aligning evidence generation with global regulatory expectations and product lifecycle requirements- Support internal and external audits, including both front-room and back-room roles, and engaging directly with notified bodies to address clinical evidence and compliance topics- Contributing to international market access strategies, integrating clinical evidence needs to support global product submissions, reimbursement pathways, and competitive positioning.
EDUCATION
The University of Tennessee Health Science Center
Postdoctoral, Epidemiology and Biostatistics
University of Jyväskylä
Ph.D., Health Sciences/Sports Medicine
Semmelweis University
B.Sc., Recreation Specialist
Semmelweis University
Ph.D., Educational and Sport Sciences/Physical Training, Regulation and Metabolic Transport Program
Semmelweis University
M.Sc., Teacher of PE and Hygiene
SKILLS
ABOUT ESZTER VÖLGYI
Clinical and medical affairs professional with outstanding execution of medical writing and clinical research in cross-functional and fast-paced environment. Excellent attention to detail and dedication with a 15+ years track record of clinical research and medical writing in both academic and industry settings. Offering outstanding project management and people management skills with comprehensive knowledge of the medical device clinical processes through cross-collaboration with multiple disciplines. Thorough understanding of MEDDEV 2.7/1 Rev 4 and EU MDR regulations related to clinical documents.
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