Regulatory Affairs Manager/Expert for Tissues of Animal Origin (AO)

Exciting challenges await on the path to realizing our vision. We are therefore seeking

Regulatory Affairs Manager/Expert for Tissues of Animal Origin (AO)

Your tasks

  • Compilation of documentation and evaluation of risks/ benefits of medical device materials made from tissues of AO (Viral/TSE Safety Evaluation Report)
  • Conducting regular zoonosis surveillance
  • Evaluating validation reports of virus inactivation studies regarding product safety
  • Submission of documentation to regulatory authorities
  • Advice on manufacturing processes and sourcing of AO tissues
  • Supporting medical device registrations in EU, USA and others

 

 Your qualifications

  • Degree in natural science, preferably in biology/veterinary medicine
  • Good understanding and experience in microbiological topics
  • Experience in systematic literature search and data evaluation
  • Awareness and understanding of how to work in a regulatory environment
  • Experience in collaborating with Notified Bodies and/or Health Authorities would be an asset
  • Collaborative, self-motivated and independent working style
  • Excellent English writing and good German communication skills

 

Our motivated team looks forward to working with you in a modern, dynamic environment with international flair.

We look forward to receiving your completed electronic application.

If you have any questions about the position, please contact: Dr. Reinhart Seibl, Director Regulatory Affairs, 041 492 55 55.





Markiert als: job_listing