20 days ago

Regulatory Affairs Specialist


  • Work region
  • Sector
  • Employment type
  • Position

Regulatory Affairs Specialist

As one of the world's leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day

Please join us as :
       Regulatory Affairs Specialist 

The regulatory affairs department is responsible for worldwide registration of the newly developed products and the existing portfolio. With newly developed class III innovative products the regulatory affairs department offers a great opportunity to work on challenging regulatory submissions.

Your responsibilities Your profile

  • Being responsible for regulatory aspects during the development of new VI products (regulatory strategy, applicable standards and guidelines)
  • Registration of VI devices in the CE and other highly regulated countries
  • Maintaining regulatory documentation up to date for worldwide regulatory purposes
  • Being responsible for implementation of regulatory aspects of labeling taking account of worldwide regulatory labeling requirements
  • Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient work flow within the department and project team
  • Coordinating and submitting deficiency responses to relevant certification bodies and country authorities
  • University degree in natural science, pharmacy, pharmacology, medicine or engineering
  • At least 2-3 years of experience with worldwide registrations of medical devices and/or combination products in relevant countries, particularly in the CE region and USA.
  • Excellent knowledge of the applicable medical device regulations in the above mentioned countries including current developments (MDR).
  • Experience in project management
  • Literate in Microsoft Office applications; SAP knowledge is an advantage
  • Independent, reliable and communicative personality who is able to deliver high quality work even under pressure and to handle several projects simultaneously
  • Fluency in English and good German (B1-Level); any other language is an advantage

Are you interested? Please apply online! We are looking forward to welcoming you.



Working hours: Vollzeit  

Type of contract: Unbefristet

Job ID: 16184

Contact: Bianca Wisner                 


We do not accept applications from Headhunters.