Description
We are looking for a
Medical Device Technical Expert - risk management (m/f)
Reference: -en
Start: 03/18
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
- Conduct and provide guidance on the use of risk analysis for use, products, components and processes
- Ensure compliance with regulatory and normative guidelines focusing on medical device risk management
- Guide internal and external functions on creating, reviewing and approving medical device risk management files
- Work with device development team to incorporate and complete risk management during all design phases for new and/or product enhancements
- Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
- Author the documentation in the medical device risk management file
Your qualifications
- Several years of experience in device development of parenteral delivery systems with main focus on medical devices
- Excellent technical writing skills (e.g., Design Controls)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
- Experience in Product Design and Design for Manufacturing
- Good technical knowledge of primary containers development and of auto injector development
- Good communication skills
- General understanding of Human Factors Engineering and risk management
- General understanding of clinical trial processes, requirements and pharmaceutical development
Skills:
- Safety officer