Regulatory Affairs Manager (m/f/x)
PreciPoint GmbH
This job is no longer available.

Regulatory Affairs Manager (m/f/x)

PreciPoint GmbH
  • Full time Position
  • Freising (Germany)
  • Published on August 10 2020
This job is no longer available.

Do you want to digitalise microscopy workflows and laboratories with us?

PreciPoint GmbH, headquartered in Freising near Munich, develops intelligent microscopy systems and innovative software solutions that digitise laboratory work for research and medical users from all application areas worldwide 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 as soon as possible at our Freising office in fulltime (40 hrs/w).

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 contact and correspondence with relevant health and regulatory authorities
  • Technical leadership in interdisciplinary project teams for product approval as representative of the Regulatory Affairs department. 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
  • Be up to date with knowledge of regulatory requirements and methods
  • Occasional business travels

Your profile

  • Several years of professional experience in the field of regulatory affairs of medical devices and experience with approval procedures in Europe, desirably also within 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 German and English

Your benefits

  • Young, fast growing company with excellent development opportunities
  • Team culture, where everyone’s ideas are heard and contribute to the overall growth
  • Flexible work 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 send your application (incl. cover letter, CV, salary expectation and soonest possible start date) as PDF
to Fiona Rosbach (Talent Recruitment) at .

This job is no longer available.