Suisse 07.06.2022

Regulatory Affairs Manager Medical Devices

Tasks

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

Requirements

  • 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)
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