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Senior Regulatory Affairs Specialist (m/f/d)

Festanstellung, Vollzeit · Krakau

Deine Aufgaben
You are thrilled to work for a company with high ethical values and would love to have an immense impact on people’s lives by helping release our products? As our Senior Regulatory Affairs Specialist (m/f/d) you’ll take ownership our Regulatory topics in a very critical role to the company’s future and help fulfil relevant national and international regulatory requirements in cooperation with our team.
  • You plan, coordinate and complete national and international medical device certification application processes and register our products in cooperation with our Product & Technology Teams    
  • Together with our Regulatory Team you are responsible for the certification process from approval strategy to documentation, in line with the medical device certification requirements (e.g. ISO standards, IVDR, FDA,)    
  • You take care of the technical leadership in our interdisciplinary project teams for product approval as representative of our Regulatory Team    
  • You maintain and review  existing technical product files, e.g. for up-to-dateness and compliance    
  • You identify / foresee regulatory requirements and changes (up-to-date regulatory strategy, reaching strategy goals)    
  • You take care of product-related risk management, from systematically identifying the current state-of-the-art to post-release risk analysis as part of    
  • You make sure that our products comply with all applicable global and regional regulatory requirements from labeling over performance to safety elements
Anforderungen
  • You have several years of professional experience in the field of regulatory affairs of medical devices and experience with approval procedures in Europe/US    
  • You have extensive experience in the cooperation with notified bodies as well as respective health and approval authorities in Europe, US and/or China    
  • You ideally have a Regulatory Affairs Certification (e.g. TÜV, etc.) or are keen to complete this with us      
  • You have completed your university education in a scientific or other relevant field    
  • You are highly communicative and able to manage information flows across departments and third parties    
  • You enjoy working in a very accurate way and have a meticulous love for detail    
  • You have a high affinity to high-tech-products and startups in MedTech    
  • You have fluent English skills
Über uns
Unsere Mitarbeiter sehen wir als den lebendigen Kern unseres Unternehmens. Ihnen eine dynamische, spannende, vor allem aber unterstützende und wertschätzende Atmosphäre zu bieten, in der ihre persönlichen Eigenschaften neben ihrer fachlichen Expertise gleichermaßen gesehen und geschätzt werden ist uns ein Anliegen. Wir sind ein Team von über 80 Experten aus mehr als 20 Nationen. Gemeinsam sind wir inveox!

Deine Bewerbung
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