JUNIOR REGULATORY AFFAIRS AND QM/PROCESS MANAGER (FULL TIME / HALF 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.

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As a Junior Regulatory Affairs and QM/Process Manager you:

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

  • Support in improvement and maintenance of our quality management system according to ISO 13485, including internal audits

  • Accompanying development projects, issuing development-accompanying and technical documentation for medical devices, 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, communication with responsible regulatory authorities (national/international) as well as with notified bodies

  • Support in risk management according to ISO 14971

  • Support of related departments

  • Digital documentation (product and process related)

  • Administration of document management systems

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Required qualifications:

  • Technical or scientific degree, e.g. biomedical engineering, informatics, 

  • Knowledge on European medical device regulations

  • 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

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Nice-to-haves:

  • Knowledge on certification process for medical device software

  • Knowledge on relevant standards (IEC 62304, ISO 13485, ISO 14971 and others)

  • Knowledge on the In Vitro Diagnostic Device Regulation IVDR

  • Familiarity with Atlassian Jira and Confluence

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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

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You’ll earn a salary starting at a minimum of EUR 35.784 per year (according to IT-KV 2021). Willingness for over-payment is given for candidates with proper experience and/or qualifications. 

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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.

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

 

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