REGULATORY AFFAIRS MANAGER, IVD MEDICAL DEVICES (M/F/D)
FULL TIME

Platomics 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. We are bioinformaticians, genetics researchers, software developers and mathematicians. 

As a Regulatory Affairs Manager you:

  • 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)

Required qualifications:

  • 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

We offer:

  • An interdisciplinary and dedicated team

  • Exciting challenges in a fast evolving domain

  • Opportunity to work on cutting-edge technologies

  • A flexible work schedule

You’ll earn a salary starting at a minimum of EUR 44.690 gross per year - career entry level (according to IT-KV). Willingness for over-payment is given for candidates with proper experience and/or qualifications. 

If you are interested in strengthening our team, please e-mail your CV.

The Platomics office is very conveniently located close to Praterstern, easily reachable via U1, U2, S-Bahn and ÖBB.

Apply via: careers@platomics.com or call +43 660 84 627 23