Description
We are looking for a
Medical device Technical Expert - Risk management (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Author of the documentation in the medical device risk management file
- Ensure timely completion and quality of the assigned risk management files
- Lead specific risk management activities within projects, as agreed with project leaders
- Manage the overall risk management program of the packaging and device development activities within the team
- Ensure compliance with ISO 14971 in all development projects under responsibility of TRD/parenteral
- Supervise risk management activities in all development projects under responsibility of TRD/parenteral
- Ensure compliance with regulatory and normative guidelines, focusing on medical device risk management
- Shape and improve the current internal risk management process for medical devices
- Guide internal and external functions on creating, reviewing and approving medical device risk management files
- Apply FDA CFR 820, ISO13485 and ISO 14971 risk management in assigned projects
Your qualifications
- Pharmaceutical education, Master or PhD
- Experience in risk management of the packaging and device development
- Experience in technical research and development issues
- Profound knowledge of quality system regulations (FDA CFR 820, ISO13485 and of ISO14971 risk management
- Fluency in English, German skills are beneficial
Skills:
- R&D scientist
- Quality manager
Keywords: Scientist R&D