Clinical Evaluation Expert

Klenico Health AG is a HealthTech company in Zurich and Berlin which has set itself the goal of helping people with mental stress or illness.

In cooperation with leading clinics in Europe we have developed a webbased CEmarked medical device software that guides healthcare professionals through the diagnostic process for mental disorders.

We are currently preparing for the MDR certification process and are looking for a Clinical Evaluation Expert to support the team and lead the clinical evaluation activities.

The main working location is Berlin or Zurich. Remote work is possible with the willingness to travel to the team every 23 weeks. A valid working permit for Switzerland or EU is required. In addition to fulltime parttime 6090% would also be an option.

Tasks

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 Klenicos 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 PostMarket Surveillance process and initiate and manage the Postmarket Clinical Followup activities.
• Work closely with crossfunctional 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.

Requirements

• Advanced degree in a clinical or related scientific field (e.g. MD PhD). Candidates who are licensed therapists psychiatrists or psychotherapists will have an added advantage.
• Knowledge in clinical psychology and diagnostic procedures of mental disorders.
• Minimum of 5 years of experience in clinical evaluation and/or related scientific work specifically with medical devices.
• Strong understanding of the clinical evaluation requirements under the Medical Device Regulation (MDR).
• Experience in leading or coordinating clinical studies is an advantage.
• Experience in medical writing.
• Fluent in English.
• At a minimum very good command of German.
• Highly selforganized team player with strong interpersonal skills.

Benefits

• A meaningful role in an innovative company that aims to solve a growing global problem and is already in use with many clinical customers
• Collaboration with a motivated and multidisciplinary team in Berlin and Zurich
• Modern office in a coworking hub in Berlin and Zurich
• Regular team events (outdoor activities team lunches and aperitifs)
• Personal development opportunities
• Attractive remuneration

We are looking forward to your application.