Medical Device Technical Expert - Basel, Switzerla
Jocelyn Blackham is recruiting for a Medical Device Technical Expert specializing within Risk management to join a global healthcare company at their site based in Basel, Switzerland on a contract basis, for 6 months with the possibility of extension.
The main purpose of the role will be to:
- Lead specific risk management activities within projects, as agreed with project leaders
- Facilitate development and completion of risk assessments
- Ensure compliance with ISO 14971 in all development projects assigned
- 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
- Author the documentation in the medical device risk management file
- Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Previous experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices for parenteral administration
- Experience generating DHF documentation
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- Excellent technical writing skills (e.g., Design Controls)
- Good technical knowledge of autoinjector development
This is an excellent opportunity to join a leading healthcare company.
For more information or to apply for this position, please contact Jocelyn Blackham on +41 (0) 417276793 or email jblackham@ckqls.ch. Please quote reference QLS42299 in all correspondence.