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Medical Device Technical Expert - Risk Management
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Design
Projektbeschreibung
Harvey Nash is looking for a Medical device Technical Expert - Risk management for a 4 month project in Switzerland.
You are responsible for
. Ensuring timely completion and quality of the assigned risk management files
. Leading specific risk management activities within projects, as agreed with project leaders
. Facilitating development and completion of risk assessments
. Managing the overall Risk Management Program of the packaging and device development activities for within the team
. Ensuring compliance with ISO 14971 in all development projects assigned
. Supervising risk management activities in all development projects assigned
. Conducting and providing guidance on the use of risk analysis for Use, Products, Components and Processes
. Ensuring compliance with regulatory and normative guidelines focusing on medical device risk management
. Guiding internal and external functions on creating, reviewing and approving medical device Risk Management Files
. Working with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements
. Applying FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
. Authoring the documentation in the medical device risk management file
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.
You are responsible for
. Ensuring timely completion and quality of the assigned risk management files
. Leading specific risk management activities within projects, as agreed with project leaders
. Facilitating development and completion of risk assessments
. Managing the overall Risk Management Program of the packaging and device development activities for within the team
. Ensuring compliance with ISO 14971 in all development projects assigned
. Supervising risk management activities in all development projects assigned
. Conducting and providing guidance on the use of risk analysis for Use, Products, Components and Processes
. Ensuring compliance with regulatory and normative guidelines focusing on medical device risk management
. Guiding internal and external functions on creating, reviewing and approving medical device Risk Management Files
. Working with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements
. Applying FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
. Authoring the documentation in the medical device risk management file
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design