Quality & Medical Regulatory Affairs Manager (m/f/d)

Quality & Medical Regulatory Affairs Manager (m/f/d)

Hybrid

Information

Work with us in an innovative start up as a Quality & Medical Regulatory Affairs Manager and support the qualitative development of our product.
Role and key responsibilities
Support the qualitative and compliant development of our product. ​You will work closely with our interdisciplinary team to change the health market sustainably. Your area of responsibility includes, for example, carrying out gap analyses, planning technical documentation and reviewing internal processes. You will be responsible for your own (partial) projects, such as improving technical documentation, the processes or other workflows, always in accordance with medical device legislation. ​You are a team player - work and communicate in a solution-oriented manner at the relevant interface between RA/QM and other departments such as development and manufacturing.
Skills and main qualifications
Education University degree in a medical or scientific/technical field OR a therapeutic or medical education with work experience in the relevant field (preferably with expertise in neurorehabilitation). Experience You either have first experience in planning, writing and controlling technical documentation for CE certification of medical devices (EU) or in the field of medical/scientific writing or with quality systems such as ISO 13485. Know-How You have first experience in dealing with clinical data, medical devices, medical software OR quality management systems in the context of ISO13485 and EU directives/MDR. Personality and way of working You are characterized by analytical thinking and a very structured way of working. Enjoy working in a team and networking with interdisciplinary stakeholders. You work in a results-oriented and precise manner when carrying out processes and documentation. Language Very good knowledge of German and English.
Company perks and benefits
Realize yourself: We work agile. With flat hierarchies and plenty of room for ideas, your work makes the difference. Create the future: With us you work on innovative, revolutionary technologies that expand the scope of what was previously possible. Experience team spirit: Regular events and sporting events are always part of it to strengthen the team spirit. Educate yourself: Our team members enjoy individual training and further education. Enjoy drinks & fruit: We provide our team with a selection of drinks and fresh fruit. Bring your dog: We warmly welcome friendly four-legged friends. Don't worry about the post: Have your parcels delivered straight to the office. There is much more that speaks for CUREosity. Apply to us or call us to find out more.
Application process
Send us your application documents so that we can get a first impression of you. We will not only assess your work history, but above all your motivation for the position and the team. Phone, online and on site: In order and quite informally. We like to take our time to get to know each other. Ask your questions and be curious about what's to come. You will receive an offer from us. If our ideas match, you will be part of our team from day 1. We will be at your side and facilitate a smooth onboarding process.
Additional information
Experience level
Entry level
Job type
Full-time
Department
Researcher / Academic
Main contact (s)
Eugenia Jordan, e.jordan@cureosity.de
Location
Düsseldorf, Germany

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