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Sr. Regulatory Affairs Manager (m/f/x) - Job Freising - Jobs

Sr. Regulatory Affairs Manager (m/f/x)

Do you want to digitalise laboratories with us?

PreciPoint GmbH, headquartered in Freising near Munich, develops intelligent microscopy systems and innovative software solutions that digitise laboratory work worldwide for research and medical users from all application areas and especially pathological cancer diagnostics.

In line with our expansion into the field of medical products, we are looking for a senior regulatory affairs specialist to join our regulatory affairs and quality management team at our Freising office on a permanent basis in fulltime (40 hrs/w) as soon as possible.

Your tasks

  • Planning, coordination and completion of national and international medical device certification application processes and registration of our products
  • 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)
  • Establishing and maintaining contact with relevant health and regulatory authorities
  • Technical leadership relating to regulatory affairs in interdisciplinary project teams for product approvals, incl. maintenance and review of existing technical product files, e.g. for up-to-dateness and compliance
  • In-house contact for internal and external inquiries, incl. provision of trainings
  • Continuous research of new and all applicable regulatory requirements and methods
  • Occasional business travels

Your profile

  • 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

Your benefits

  • Young, fast growing company with excellent development opportunities
  • Team culture, where diversity is used to create the best possible solutions
  • Flexible working hours

You fit our team, if you are passionate about technology, inspiring projects and a fast paced, dynamic work structure, where you can quickly take over responsibility and realise your ideas.

Does that sound like you?

Then upload your application (incl. cover letter, CV, salary expectation and next possible start date) as PDF to our portal. Fiona Rosbach (Talent Recruitment) will then get in touch with you to arrange the next steps.

Locations

Alois-Steinecker-Str. 22, 85354 Freising, Germany