XUND
Regulatory Affairs Manager f/m/d
Budapest or Vienna
Full time
XUND is a leading digital health start-up that enables healthcare companies to digitize patient interactions and translate unstructured data into actionable insights.
It's our vision to improve the quality and accessibility of healthcare by bringing together medicine, technology, and a human-centered mindset. But we cannot do it alone: we need leaders, doers, and innovative minds to turn our vision into reality.
That is why we are looking for an ambitious, highly committed, and entrepreneurial individual who shares our values of purpose, openness, courage, collaboration, and integrity and can contribute to our growth and long-term success.
Your responsibilities
- Support the product development compliant with the Medical Device Regulation (MDR)
- Work closely with the development team in setting up lean processes to ensure compliance with regulatory requirements
- Keep the technical file of our medical devices up-to-date and communicate with authorities accordingly
- Support the quality team in internal and third-party audits
- Ensure overall compliance with national and international regulatory requirements
Your profile
- Degree in a relevant field (e.g. life sciences, law, engineering) or equivalent industry experience
- Knowledge of the relevant standards for software as a medical device (IEC 62304, ISO 14971, IEC 62366, etc.)
- Technical understanding, love for innovative apps or software development, and experience working in agile environments
- Experience with audits and Notified Bodies
- Curious, problem-solving mindset and interest in gaining new knowledge
- Excellent written and verbal communication skills in English
Nice to have
- Knowledge of the medical device industry
- Experience with Atlassian products (e.g. Jira, Confluence)
- Basic knowledge of information security management systems (ISMS)
- Experience with FDA and MDSAP audits
Benefits
- Become part of one of the fastest-growing health tech start-ups in Europe
- Challenging tasks in a highly innovative and dynamic environment
- Work in our brand new offices in the hearts of Budapest and Vienna or fully remote
- A lively, open corporate culture with flat hierarchies and short communication channels
- Office dogs, which (mostly) contribute to a relaxed working atmosphere
The minimum salary for this position is according to the IT collective agreement (EUR 3.190 gross monthly salary for full-time employment). Willingness to overpay is given and depends on the specific qualification and experience.
How to apply
Are you interested?
Apply using the form on our website and tell us why you are the right person for the job.
XUND
XUND enables healthcare organizations to build their own digital patient journey and translate unstructured data collected from patients into actionable insights. Founded in 2018, the Vienna-based company’s core product is an AI-powered technology that provides symptom and risk assessment to give patients a reliable initial assessment and guide them to the best place for treatment.