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Contractor in Regulatory Affairs/ Quality

vor 2 Wochen

Berlin, Deutschland Fosanis GmbH Vollzeit

**Your mission**:

- Review and update our current technical documentation
- Write any missing documents and compile them for our MDR submission
- Assist the Regulatory Affairs manager in various projects
- Support internal and external audits
- Support in closing the CAPAs from audits

**Your profile**:

- Relevant professional experience in regulated industries or quality management systems dealing with medical devices. Software as a medical device would be a plus
- Practical knowledge of EN ISO 13485 and Regulation (EU) 2017/745 is a must
- Experience with EN 62304 and EN 62366-1 is desirable
- Experience in writing technical documentation for medical devices
- Spoken and written English is a must
- Experience in project management
- Independent, structured and efficient way of working
- Based in Germany, 3 days in Berlin in August are a must

**Why us?**:
**Make an impact**
People affected by cancer experience distress, fatigue and many other symptoms but many face difficulties in accessing help to manage their experience beyond medical treatment. Your work will have a great impact on the life of each individual we serve.

We are Mika - a digital health startup based in Berlin. Driven by the vision of empowering people affected by cancer, we have developed a digital companion for cancer patients: the Mika app. Our approach is rooted in psycho-oncology. As the German market leader in the field of digital therapeutics for cancer patients, we have a rapidly growing, international team and are constantly looking for new talent. Our vision expands beyond an app world and Germany because we want to empower as many individuals as possible.

Mika was developed by the digital health company Fosanis in collaboration with leading oncological research institutions and cancer centres, such as the University of Leipzig Medical Center and Charité Berlin.