REGULATORY AFFAIRS MANAGER, MEDICAL DEVICES (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. Contact us if you love to code and work with other developers to build meaningful products.

As a Regulatory Affairs Manager you:

  • Support in implementation of In-Vitro Diagnostics Regulation IVDR (EU 2017/746) and fulfilling regulatory requirements

  • Accompany development projects, issuing development-accompanying and technical documentation for medical devices

  • 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 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

  • Convenient office location close to U1, U2 and U4 metro station Karlsplatz in Vienna

You’ll earn a salary starting at a minimum of EUR 35.784 gross per year - career entry level (according to IT-KV 2021). 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.

Platomics´ office is very conveniently located close to the metro station of U1, U2 and U4 Karlsplatz.

Apply via: careers@platomics.com or call +43 660 222 03 95