Description
We are looking for a
Risk Manager Medical Devices (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Ensure timely completion and quality of the assigned risk management files
- Lead specific risk management activities within projects, as agreed with project leaders
- Facilitate development and completion of risk assessments
- Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements
- Ensure compliance with ISO 14971 in all development projects assigned
Your qualifications
- Excellent technical writing skills (e.g. Design Controls)
- Good understanding of medical device regulations (FDA 21 CFR 820, EU Medical Device Directive) and of combination products
- Experience in Product Design and Design for Manufacturing
- Good technical knowledge of primary containers development
- General understanding of pharmaceutical development, clinical trial processes and requirements
- Fluent English skills
Skills:
- Project manager