Clinical Evaluation Expert

Vor 5 Tagen

Zurich, Schweiz Klenico Health Vollzeit

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 web-based, CE-marked 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 2-3 weeks. A valid working permit for Switzerland or EU is required. In addition to full-time, part-time 60-90% 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 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.

**Requirements**:

- 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 self-organized 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

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