Risk Management Expert - Medical Devices

We have an opportunity for a medical devices expert to take on a project focusing on risk management assessment of the assigned combination devices portfolio.

Tasks:

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.

Requirements:

Already gained experience in device development of parenteral delivery systems, eg, drug/device combination products with main focus on medical devices for parenteral administration.

generating DHF documentation.
Excellent technical writing skills (eg, 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
Good technical knowledge of autoinjector development
Good communication skills
General understanding of Human Factors Engineering and Risk management
General understanding of clinical trial processes and requirements
General understanding of pharmaceutical development
Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.