Risk Manager - Medical Device-User Interface
Life Science Recruitment has been exclusively engaged to source a Risk Manager for our client in Dublin. The ideal candidate will demonstrate subject matter expertise in the application of FDA and EU regulations and international standards related to design control, user interface and risk management. The individual must also possess an interest in maintaining an awareness of the device development landscape and have the technical drive and confidence to represent our client from an external perspective where necessary.
The Risk Manager will be vital to the development program from concept through to regulatory submission and product lifecycle management. At the beginning of a development program, your role will be to contribute to device design & development, risk management plans, development of user-related design inputs and lead user-focussed risk assessments. Through your understanding of the intended use, foreseeable misuse and therapeutic benefit of the drug delivery device, medical device or medical technology you will collaborate with human factors engineers, design engineers, clinicians and pharmacovigilance teams to analyse, evaluate, mitigate and control risks at the user interface in line with international standards and the internal quality management system our client adopts.
Scientific Knowledge & Exchange
Possesses subject matter expertise of the FDA & EU regulatory & standards landscape pertaining to device design and risk management.
Demonstrable experience of risk management and design controls (preferably in user-focussed risk management) in the medical device or pharmaceutical Industry.
Strategic thinker in the inter-relationship between user-focussed risk management and device design & development.
Appropriate Science or Engineering Degree.
Excellent verbal and written communicator who is clear and concise in communications with internal and external partners.
James Cassidy | Tel: +353 (0) 1 5079250