(Junior) Manager Quality Management / Regulatory Affairs Medical Software (f/m/x)
- Berlin, Germany | full-time | from now on
Curalie is a young, agile company in a unique location in Berlin-Mitte. Since 2017, we have been turning innovative ideas into digital offers for patients and practical tools for health care professionals. Our goal: to move patients, actively work towards health goals and improve their quality of life on their own responsibility. For this we need masters of motivation who do not want to instruct users, but can inspire them.
How you support us
- Manage the continual process development (of e.g. our go-to-market processes) in the regulatory context of a Medical Software Platform
- Support and advise our specialist departments in regulatory process matters
- Operative Activities of QM specific processes (internal audits, product change management)
- Manage and support medical software approval and registration processes (especially focused on MDR Software Requirements)
- Keeping your knowledge up to date in specific areas of regulation (e.g. DVG, MEDDEV Guidances)
- Manage and support the roll-out of a QMS to acquired companies (incl. occasional business trips)
What sets you apart
- Academic degree (Bachelor/Master/Diplom) in a technical field in combination with (first) regulatory experience in an international company
- Distinctive (technical) written and verbal communication skills as well as the ability to effectively communicate and collaborate with internal and external stakeholders
- Ability to read and interpret technical and regulatory documents
- (First) experiences with the structure of and work in quality management systems (desirable: DIN EN ISO 13485)
- Knowledge of medical guidance documents, such as MEDDEV
- Familiarity with the European Medical Device Regulation and Harmonized Standards
- Fluency in English and German is mandatory
What we offer you
- We give you a lot of responsibility, variety and the opportunity to develop with us.
- You can expect a unique workplace in Berlin-Mitte with many advantages (flexible working hours, further training, a subsidy for your BVG ticket, your physical well-being is taken care of, …).
- We are an agile team of smart scientists, product people, developers, doctors and therapists and cosmopolitan personalities like you.
- Talent, commitment and team spirit are more important to us than titles and certificates.
- Your participation in our meaningful products contributes to improving the quality of life of patients and their families.
Interested? Contact us!
We help people to live healthier lives – would you like to support us on this way?
Please send your application documents with the earliest possible starting date and your desired salary to our applicant mailbox: email@example.com