Clinical Evaluation Expert

As a Clinical Evaluation Expert, you will be responsible for leading the clinical evaluation process of our medical device software, ensuring compliance with the EU Medical Device Regulation (MDR) and overseeing all clinical research activities. Your expertise will guide the development, execution, and analysis of clinical data and activities, ensuring that our product meets rigorous clinical and regulatory standards.

• Responsible for the strategy and execution of the clinical evaluation for Klenico’s medical device.
• Further develop and implement comprehensive clinical evaluation plan to assess the safety and performance of the software.
• Analyze and interpret clinical data, prepare and manage the clinical evaluation report, and contribute to regulatory submissions.
• Lead the design and execution of clinical studies.
• Support the Post-Market Surveillance process and initiate and manage the Post-market Clinical Follow-up activities.
• Work closely with cross-functional teams, including R&D, product development, risk management, and regulatory affairs, to provide input for the product design and development processes.
• Manage relationships with external partners, including clinical investigators, CROs, and other stakeholders.