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
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
Knowledge on international medical device approval procedures (e.g. FDA)
Knowledge on Genetic Testing
Familiarity with Atlassian Confluence and/or JIRA
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: or call +43 660 222 03 95