Clinical Evaluation Specialist

Our partner is a California-based, innovative medical technology company with 10,000 employees globally and 500 employees in Hungary. Through their manufacture of medical devices and development of software for treating oncological diseases, they are driving groundbreaking advances in healthcare. Now they are looking to expand their Medical Affairs team of 6 members with a Clinical Evaluation Specialist.

Responsibilities 

• Assist in conducting clinical assessments and ongoing post-market monitoring activities, which involves customer feedback collection, scientific literature research, clinical investigations.
• Contribute to the development and documentation of Clinical Evaluation and Post-Market Monitoring strategies and reports (CEP/CER and PMCFP/PMCFR).
• Provide clinical insights and guidance to multidisciplinary teams, including risk management, product management, and post-market surveillance groups.
• Review marketing and promotional materials from a clinical perspective to ensure accuracy and compliance before release to customers.

Requirements

• EU citizenship or existing work permit for Hungary
• (Visa sponsorship is not offered; candidates must have the legal right to work in Hungary)
• Business professional English knowledge
• Understanding of clinical evaluation and post-market follow-up requirements for medical devices in accordance with the European Union Medical Device Regulation (EU MDR)
• At least 2 years’ experience with clinical evaluations, medical writing, medical physics, or related fields
• Master’s or PhD degree in Medical Physics, Biophysics, Biomedical/ Medical Engineering or a related field

Our partner offers

• Excellent remuneration package including base salary, bonuses, and benefits
• 4 days Home Office/week
• Language courses
• Private health insurance
• Autonomy-driven work environment
• Further career opportunity as a Clinical Evaluation Manager