Technology, Information and Internet

Klenico Health

11-50

Switzerland

We have developed a software as a medical device (SaMD) that guides through the diagnostic process for mental disorders. It is currently certified as an MDR class I legacy device. The main task is to lead the new MDR class IIa certification process and ensure that all regulatory requirements are met. 

Our ideal person thinks strategically, solves problems creatively as they arise, bridges the gap between hyper-vision and vision, and has a hands-on mentality.

This position is part of Klenico's leadership team. In addition, the daily role is to communicate with external as well as internal stakeholders.

The main working location is Berlin or Zurich. A valid working permit for Switzerland or the EU is required. Remote work is possible with the willingness to travel to the team every 2 weeks.

## Tasks

*   You drive the Quality Management and Regulatory Affairs areas strategically and operationally, taking the company to the next level.
*   This includes the preparation, implementation and continuous improvement of all processes required for MDR such as post-market activities, change management, internal audits, and communication with notified bodies and regulatory authorities.
*   You ensure that relevant standards and norms are met (e.g. ISO 13485, IEC 62304, ISO 62366-1) for both the EU and the Swiss market.
*   You are the Quality Management Representative and perform the formal and substantive tasks of the Person Responsible for Regulatory Compliances (PRRC).

## Requirements

*   Relevant studies and several years of professional experience in Regulatory Affairs & QMS with software as a medical device
*   Formal requirements for PRRC fulfilled
*   Experience with DiGAs is a plus
*   Work experience in a start-up / small organization environment
*   Organizational talent with a pragmatic approach and an eye for detail
*   Preferably experience in building and leading teams
*   Enthusiasm for solving interesting problems, curiosity and adaptability
*   Excellent oral and written communication and presentation skills in English
*   At least intermediate German Skills are required, since internal documents are predominantly in German
*   Strong and empathetic communicator

## Benefits

*   Dynamic UZH startup with a talented, diverse and committed team in Berlin and Zurich
*   Varied and exciting work with a high level of personal responsibility
*   Modern office in a coworking hub, home office 2-3 days a week possible
*   Meaningful work in a company that is all about mental health
*   Regular team events (outdoor activities, team lunches and aperitifs)
*   Personal development opportunities

We look forward to receiving your application. Interviews will take place in September.

Employee

Manager

<p>We have developed a software as a medical device (SaMD) that guides through the diagnostic process for mental disorders. It is currently certified as an MDR class I legacy device. The main task is to lead the new MDR class IIa certification process and ensure that all regulatory requirements are met. </p>
<p>Our ideal person thinks strategically, solves problems creatively as they arise, bridges the gap between hyper-vision and vision, and has a hands-on mentality.</p>
<p>This position is part of Klenico&#39;s leadership team. In addition, the daily role is to communicate with external as well as internal stakeholders.</p>
<p>The main working location is Berlin or Zurich. A valid working permit for Switzerland or the EU is required. Remote work is possible with the willingness to travel to the team every 2 weeks.</p>
<h2 id="tasks">Tasks</h2>
<ul>
<li>You drive the Quality Management and Regulatory Affairs areas strategically and operationally, taking the company to the next level.</li>
<li>This includes the preparation, implementation and continuous improvement of all processes required for MDR such as post-market activities, change management, internal audits, and communication with notified bodies and regulatory authorities.</li>
<li>You ensure that relevant standards and norms are met (e.g. ISO 13485, IEC 62304, ISO 62366-1) for both the EU and the Swiss market.</li>
<li>You are the Quality Management Representative and perform the formal and substantive tasks of the Person Responsible for Regulatory Compliances (PRRC).</li>
</ul>
<h2 id="requirements">Requirements</h2>
<ul>
<li>Relevant studies and several years of professional experience in Regulatory Affairs &amp; QMS with software as a medical device</li>
<li>Formal requirements for PRRC fulfilled</li>
<li>Experience with DiGAs is a plus</li>
<li>Work experience in a start-up / small organization environment</li>
<li>Organizational talent with a pragmatic approach and an eye for detail</li>
<li>Preferably experience in building and leading teams</li>
<li>Enthusiasm for solving interesting problems, curiosity and adaptability</li>
<li>Excellent oral and written communication and presentation skills in English</li>
<li>At least intermediate German Skills are required, since internal documents are predominantly in German</li>
<li>Strong and empathetic communicator</li>
</ul>
<h2 id="benefits">Benefits</h2>
<ul>
<li>Dynamic UZH startup with a talented, diverse and committed team in Berlin and Zurich</li>
<li>Varied and exciting work with a high level of personal responsibility</li>
<li>Modern office in a coworking hub, home office 2-3 days a week possible</li>
<li>Meaningful work in a company that is all about mental health</li>
<li>Regular team events (outdoor activities, team lunches and aperitifs)</li>
<li>Personal development opportunities</li>
</ul>
<p>We look forward to receiving your application. Interviews will take place in September.</p>


Senior Regulatory Affairs & QMS for a medical software company in mental health 

Freelance

Freelance Psychotherapeut/in (französischsprachig/italienischsprachig)

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