Regulatory Affairs Manager (m/f/x)
We digitize microscopy and laboratory workflows
PreciPoint GmbH, soon located in Garching near Munich, develops intelligent microscope systems and innovative analysis software, thus contributing to the digitalisation and further development of laboratories. Our customers range from medical laboratories and research institutions to industry.
In line with our expansion into the field of medical products, we are looking for a Regulatory Affairs Manager (m/f/x) to join our team at our future office in Garching on a permanent basis as soon as possible.
- Responsibility for certification processes from approval strategy to documentation, in line with the requirements of medical device certification requirements (e.g. ISO, IVD, FDA, CFDA)
- Person Responsible for Regulatory Compliance (PRRC IVDR)
- Planning, coordination, and completion of national and international IVD medical device certification application processes and registration of our products
- Continuous research of new and all applicable regulatory requirements and methods
- Establishing and maintaining contact with relevant health and regulatory authorities
- Be part of interdisciplinary development project teams and support for example with maintenance and review for up-to-dateness and compliance of existing technical product files
- In-house contact for internal and external inquiries, incl. provision of trainings
- Strong professional track record with the regulatory affairs of medical devices, incl. successfully completed approval procedures in Europe; ideally also for the US and Chinese market
- Extensive experience in the cooperation with notified bodies as well as respective health and approval authorities in Europe, China, and the US
- In-depth knowledge of development processes for soft- and hardware components
- Highly communicative and able to manage information flows across departments and third parties
- Goal-oriented even in complex and adverse situations
- Independent, highly structured, and organised way of working
- Analytical and creative in identifying and solving potential issues
- Fluency in written and spoken German as well as English
- Fast promotion opportunities and numerous training measures
- A young, dynamic, and multicultural team with more than 10 different nationalities
- Flexible working hours and home office option in a trusting and family-friendly company
- Tailor-made introduction program
- An open, positive, and constructive feedback culture where feedback is given both ways
- Free drinks and healthy snacks
- Corporate benefits with well-known partners
- Regular team building activities
Join PreciPoint and make a positive impact on the future of our health system!
Does that sound like you?
You fit in our team if you aspire achieving professional success and enjoy working in a dynamic environment where you can quickly take on personal responsibility and realise your own ideas.
Just upload your application (incl. CV and soonest possible start date) as PDF here in our portal. If you have any questions, please contact Anne Bohrmann from our recruiting team. We look forward to hearing from you!
Scope of activitiesProcess planning and quality assurance