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. 

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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)

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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

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Preferred Qualifications:

• Knowledge on international medical device approval procedures (e.g. FDA)

• Knowledge on Genetic Testing

• Familiarity with Atlassian Confluence and/or JIRA

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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

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You’ll earn a salary starting at a minimum of EUR 44.660 gross per year - career entry level (according to IT-KV). 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.

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

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