Regulatory Affairs Manager

XUND is a leading digital health scale-up that enables healthcare companies to digitize patient interactions and translate 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 team player who shares our values of putting patients first, building an inspiring and open environment and challenging the status quo.

The Role

Are you ready to shape the future of healthcare from the ground up? Join XUND as a Regulatory Affairs Manager, who’s excited to support smart, scalable solutions. As part of the highly motivated Quality Management team you ensure that our medical devices meet EU MDR and global regulatory requirements. Working closely with cross-functional teams you support product development, maintain technical files, oversee clinical studies and investigations and help improve the QMS. In a culture that takes quality and safety seriously, play a key role in audits and communication with authorities.

Your Responsibilities

• Support product development compliant with the EU Medical Device Regulation (MDR)

• Collaborate across departments to improve processes of the quality management system (QMS)

• Keep the technical file of our medical devices up-to-date and communicate with authorities accordingly

• Oversee clinical studies and investigations in line with applicable standards and regulations

• Participate in internal and third-party audits

• Ensure overall compliance of our products and our management system with national and international regulatory requirements

Your Profile

• Degree in a relevant field (e.g. life sciences, law, engineering)

• 3+ years of industry experience including participation in audits

• Strong 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 clinical studies and investigations

• Curious, problem-solving mindset and interest in gaining new knowledge

• Excellent written and verbal communication skills in English

• Resident in the European Union and authorized to work

Nice to have

• Experience with Atlassian products (e.g. Jira, Confluence)

• Basic knowledge of information security management systems (ISMS) 

• Experience with FDA and MDSAP audits

• Proficiency in Hungarian or German language

Your Benefits

• Embark on a journey with one of Europe’s fastest-growing digital health scale-ups and make a real impact in a purpose-driven environment!

• Take on exciting challenges while working in a dynamic space where creativity and fresh ideas are always encouraged.

• Benefit from a dedicated training budget and professional development time, because we believe in growing together and supporting your skill-building journey.

• Enjoy the flexibility to work from wherever suits you best – whether that’s your cozy home office, a café down the street, or one of our offices in Vienna, Budapest, or London.

• Join regular team events at each office and several company-wide celebrations throughout the year to connect with colleagues, share experiences, and create lasting memories.

• Be part of a vibrant, open culture with flat hierarchies and direct communication, where your voice matters and everyone’s ideas are heard.

• Plus, office dogs! They're here to keep the vibes chill and remind us all to take a paws and relax.

At XUND, we know that innovation happens when different perspectives come together. Whether you’re a coding whiz, a health enthusiast, a spreadsheet guru, or a creative problem-solver, we value what you bring to the team. If you’re excited about this role but feel like you don’t “check all the boxes,” don’t worry – we still want to hear from you! We’re committed to fostering an inclusive space where everyone’s contributions are valued and respected, and we encourage candidates of all backgrounds, identities, and experiences to apply. If you’re eager to make an impact, we’d love to hear from you!