Regulatory Affairs Manager Medical Devices
AIXIAL is an international Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies.
We are currently hiring Regulatory Affairs Managers for Medical Devices.
Primary Tasks & Responsibilities:
- Liaise with the FDA, other regulatory authorities, internal and external stakeholders
- Develop regulatory strategies in coordination with internal and external stakeholders
- Prepare regulatory submission documentation with main focus on USA and Canada, US submission support 510(k) Premarket Notification
- University degree in Life Sciences
- Experience in Regulatory Affairs submission to the FDA
- 5 years of Experience with Medical Devices
- Fluent English and ideally good command of German (at least a B1 Level)