Munich · full-time (min. 32 h / week negotiable) · permanent · starting as soon as possible · reporting directly to the management
CollimateHealth is a TUM-Spin-off at the intersection between physics, engineering and health. We have been awarded “science breakthrough of the year 2025” in health by Falling Walls and recently closed our first oversubscribed investment round.
We develop the world’s first clinically scalable microbeam radiation technology designed to reshape the way cancer is treated. Until now, microbeams could only be produced at large synchrotrons; with our compact source, we reduced the space needed to less than 10 m². Now, we are building the first clinical devices as a class IIb device under EU MDR 2017/745 – and we need you to be part of our team.
As our first regulatory hire, you shape the strategy that takes the world's first clinically scalable microbeam therapy device from prototype to first-in-human and international market approval.
What you bring:
- University degree in engineering, natural sciences, medical technology, pharmacy, chemistry, biology, or a related field — or, alternatively, at least four years' experience in regulatory affairs/QM for medical devices.
- Professional experience with medical device certification and approval in a regulated environment.
- Experience with ISO 13485 implementation, internal audits, and design control.
- Proficiency in written and spoken English; German at B2+ or the commitment to get there.
What you do:
- You shape the regulatory strategy for our first clinical device – from first-in-human through international approval processes.
- You take on the role of Person Responsible for Regulatory Compliance (PRRC) under Article 15 MDR, depending on your experience.
- You build our QMS from the ground up and take it through ISO 13485 certification.
- You establish risk management per ISO 14971 and our design control / design history file.
- You author and own the technical documentation for CE marking and international clearances (FDA among others).
- You lead our interactions with the Notified Body, BfArM, Bundesamt für Strahlenschutz, and the ethics committee.
- Together with our physicists, engineers, and clinicians, you ensure compliance across the standards landscape – including IEC 60601-1 and the applicable particular standard, IEC 62304, MDCG guidance, and radiation specific regulations, including German StrlSchG/StrlSchV.
- You monitor regulatory developments and translate them into concrete actions for the team.
What we offer:
- A fascinating technology – a real moonshot in engineering, physics and health sciences.
- A workplace full of talented and down-to-earth people from all over the world. A workplace with zero politics or hidden agendas. A workplace where you can own your stuff and get things done. A workplace where everyone is passionate about making an impact.
- This is where the future of cancer therapies happens. This is where work equals passion. This is the place where great potentials are unlocked.
- We provide clear career prospects, a dynamic, growing environment and the opportunity to actively shape things and we celebrate our successes with a variety of events.
- Flexible working hours, hybrid work, 30 days vacation and your own budget for individual training on the job.
- Employee Participation Program (VSOP)
- Working in one of the world’s most livable cities; we are easily reachable and have a vibrant location in the Werksviertel close to Ostbahnhof.
Data Protection
- We process your personal data for the purpose of managing the recruitment process and assessing your application. For detailed information on how your data is processed, including your rights, please refer to our Privacy Policy.
#J-18808-Ljbffr
