Regulatory Affairs Manager IVD (m/w/d)

Wien Festanstellung EUR50,000 - EUR75,000

Aktualisiert am 09/03/2022

  • Fast growing start up
  • Medical devices

Firmenprofil

Our client develops a global marketplace for personalized medicine to make the future of molecular diagnostics available today. We are a young vibrant team and apply the most advanced computing technologies to enable big data processing and analysis in healthcare.

Aufgabengebiet

  • Support in implementation of In-Vitro Diagnostics Regulation IVDR (EU 2017/746) and fulfilling regulatory requirements
  • Participate in development projects, issuing development-accompanying and technical documentation for medical devices
  • Establish regulatory compliance strategies for different IVD medical devices under the IVDR
  • Support in the creation of technical documentation, revising already existing technical documentations
  • Support in examination of the conformity and taking part in the conformity assessment
  • Support in the certification process of our medical software products
  • Communicate with responsible regulatory authorities (national/international) as well as with notified bodies
  • Support in risk management according to ISO 14971
  • Work in Post-Market Surveillance
  • Support related departments, e.g. with internal trainings
  • Contribute to our digital documentation (product and process related)



Anforderungsprofil

  • Technical or scientific degree, e.g. biomedical engineering, informatics
  • European medical device regulations, in particular on the In Vitro Diagnostic Device Regulation IVDR
  • Knowledge on certification process for medical device software
  • Knowledge on medical device product development processes
  • Knowledge on further relevant standards (IEC 62304, ISO 14971 and others)
  • Sense of responsibility, reliability, high carefulness and accuracy in the way of working
  • Taking actions purposefully and structured
  • Very good German and English language, spoken and written
  • Self-organizing, meeting deadlines
  • Team player



Preferred Qualifications:

  • Knowledge on international medical device approval procedures (e.g. FDA)
  • Knowledge on Genetic Testing
  • Familiarity with Atlassian Confluence and/or JIRA

Vergütungspaket

  • An interdisciplinary and dedicated team
  • Exciting challenges in a fast evolving domain
  • Opportunity to work on cutting-edge technologies
  • A flexible work schedule
Referenznummer
JN-032022-5378969

Zusammenfassung

Nach Berufsfeld suchen
Life Sciences
Näheres Berufsfeld
Regulatory Affairs
Branche
Healthcare / Pharmaceutical
Ort
Wien
Vertragsart
Festanstellung
Referenznummer
JN-032022-5378969