Risk Manager Device Development (auto injector )

Switzerland  ‐ Vor Ort
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Beschreibung

For my client, a global Life Science Company in Switzerland,i am currently looking for a Risk Manager for the development of Drug Delivery Devices.

The assignement is for a 1 year contract with a huge chance to get extended, please take a look:

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.


Professional Experience:
  • An ideal candidate would have at least 8 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.
  • Requirement for the role are:
  • Excellent technical writing skills (e.g., 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 auto injector 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


If you think that you can fulfil the requirements above and if you are keen to discuss the general job market situation in Switzerland, please do not hesitate to get in contact with me.
Best Regards
Sabina Keel
Start
03/2017
Dauer
10
Von
Real Staffing
Eingestellt
18.02.2017
Projekt-ID:
1290979
Vertragsart
Freiberuflich
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