PERFORMANCE EVALUATION MANAGER (IVDR)  (M/F/D)
FULL TIME

Platomics is dedicated to bringing the power of personalized medicine into everyday healthcare by making genetic testing easy and affordable. For this purpose, our team applies the most advanced computing technologies to enable big data processing and analysis in healthcare. We are a vibrant team, with backgrounds in bioinformatics, genetics and software development.
 

As a Performance Evaluation Manager you have the following responsibilities:

  • Manage the performance evaluation of our IVD software products according to European Regulations (IVDR)

  • Create and maintain Performance Evaluation Plans and Reports, including Analytical and Clinical Performance Evaluation, including stability tests

  • Define relevant evaluation measures and design study protocols

  • Prepare and submit ethics applications; communication to authorities, e.g. ethics committee, competent authorities

  • Management of clinical performance evaluation and trials; coordinate study partners (e.g. in multi-centric trials)

  • Collect and manage relevant literature

  • Assessment of literature, document Scientific validity

  • Coordination of Post-market performance follow-up PMPF (planning, design, analysis, documentation)

  • Collaborate with external stakeholders involved in the performance evaluation, e.g. geneticists or physicians

  • Work with cross-functional teams, especially Regulatory Affairs and Quality Management, Engineering
     

Required Qualifications:

  • Degree qualification in medicine or related science subject, laboratory and/or medical and/or clinical background

  • Experience with Performance Evaluation under IVDD/IVDR, including Analytical and Clinical Performance Evaluation

  • Industry experience and mindset

  • IVDR Regulatory knowledge preferred; MDR optional

  • Experience in clinical trials (setup and management), ethics applications

  • Strong organizational skills

  • Excellent communication skills

  • Very good English skills, especially writing in English
     

Preferred Qualifications:

  • Knowledge on regulatory standards and Performance Evaluation of medical or diagnostic devices

  • Knowledge of genetic testing

  • Translation of a device into clinical practice

  • Regulatory Experience with reagents, wet-lab, lab chemicals

  • Experience with software as medical device (SaMD), software as an IVD

  • Experience in scientific writing

  • Experience with medical literature and publication databases

  • Knowledge of International Regulations, e.g. FDA

  • German language skills
     

We offer:

  • Interesting topics in a rapidly growing market

  • Challenging and varied tasks

  • Flexible work schedule 
     

You’ll earn an appropriate salary starting at EUR 44.660  gross per year (IT-KV). Willingness for over-payment is given for candidates with proper experience and/or qualifications.

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

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