Medical device Technical Expert - Risk management 00024655
Our client is a successful company in the pharma industry.
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.
Ensure compliance with ISO 14971 in all development projects assigned
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
Start of work
Immediately / by agreement
An ideal candidate would have at least 5 years of experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices for parenteral administration. The ideal candidate would have experience generating DHF documentation.