Senior Regulatory Affairs

vor 2 Monaten

Berlin, Deutschland Klenico Health Vollzeit

We are looking for a leader who will support us in ensuring 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.

Interviews will take place from mid-August. The main working location is Berlin or Zurich. Remote work is possible with the willingness to travel to the team every 2-3 weeks.

Tasks
- You are a pro-active part of the leadership team.
- You drive the Quality Assurance and Regulatory Affairs areas strategically and operationally, taking the company to the next level.
- You develop the regulatory and quality assurance strategy within the OKR framework and ensure that it is achieved. On the one hand, this includes the preparation and implementation of the certification according to class IIa MDR as well as the fulfilment of all regulatory requirements post-market according to MDD as legacy device or MDR. At the same time, the further development and certification of the QMS according to ISO 13485 falls into your area of responsibility.
- You are the quality representative and perform the formal and substantive tasks of the person responsible for regulatory compliances (PRRC).
- Preparation of audits by notified bodies and inspections by authorities, including continuous communication.

**Requirements**:

- You are a pro-active part of the leadership team.
- Relevant studies and several years of professional experience in the MedTech sector or in a regulated environment (preferably software)
- Formal requirements for PRRC fulfilled
- Work experience in a start-up environment
- Organisational talent with a pragmatic approach and an eye for detail
- Experience in building and leading teams
- Preparation of audits by notified bodies and inspections by authorities, including continuous communication.
- Enthusiasm for solving interesting problems, curiosity and adaptability
- Excellent oral and written communication and presentation skills in English, German an advantage
- Strong communication skills

We are open to German or English-speaking applicants. A basic or good level of German is highly appreciated to better be able to connect with the team.

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