Exciting challenges await on the path to realizing our vision. We are therefore seeking
Regulatory Affairs Manager/Expert for Tissues of Animal Origin (AO)
- 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
- 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.