Senior Regulatory Affairs Specialist (m/f/d)

Über uns

Ob die Liebe zum Detail von zwei perfekt ineinandergreifenden Zahnrädern oder die Begeisterung mit neuer Technologie die Welt des Kunden zu verändern – jeder hat seinen eigenen Antrieb. Dennoch eint uns alle der Wunsch, Krebsdiagnosen zuverlässiger und schneller zu machen: ob aus persönlicher Erfahrung oder der Hingabe zu der zugrundeliegenden Technologie. Jeden Tag einen Schritt näher hin zu unserem Ziel.

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