Teamleader Safety for Vascular Intervention Products (m/f)
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
: Teamleader Safety for Vascular Intervention Products (m/f) Your ResponsibilitiesYour Profile
The Medical Affairs Group in Switzerland is responsible for the design, conduction and evaluation of international first-in-men clinical studies and post-marketing trials. The department is growing and offers a challenging environment for professionals who want to take part in our success.
- Responsible for the safety and compliance group including leadership of the team and overall responsibility for the safety guidelines and regulations
- Act as an interface to all groups within the Medical Affairs Group, regulatory bodies and external authorities
- Responsible for tracking and solving adverse events and writing periodic reports for different boards and committees
- Safety & compliance interactions with third parties (e.g. CEC / DSMB, clinical investigators, medical- and regulatory experts, vendors, statisticians, etc.)
- Define and assign trainings to Medical Affairs members as well as performe internal Medical Affairs audits
- BA/BS/MS or international equivalent and at least 5 year's experience in safety reporting or clinical quality assurance
- Experience in interacting with clinical- and ethic committees as well as with competent authorities
- Able to manage multiple projects in interdisciplinary multicultural teams
- Knowledge in GCP / ISO and experience in class II or III medical devices
- Bridge-builder, coach who likes to develop processes and understands to interact with different stakeholders
- Fluency in German & English is a must
Are you interested? Please apply online! We are looking forward to welcoming you.
Working hours: Vollzeit
Type of contract: Unbefristet
Job ID: 4330
Contact: Ivan Urenda
We do not accept applications from Headhunters.