Device Technical Expert in Risk Management

CH  ‐ Vor Ort
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Beschreibung

Main Task

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.

Requirements:

Solid experience in device development (ideally parenteral delivery systems, eg, drug/device combination products) generating DHF documentation. 
Technical writing skills (eg, Design Controls) 
Medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
Product Design and Design for Manufacturing 
Knowledge of autoinjector development

Please send your CV

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

Start
18/06/18
Dauer
6 months
Von
Michael Bailey Associates - Zurich
Eingestellt
05.06.2018
Projekt-ID:
1565515
Vertragsart
Freiberuflich
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