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Medical Device Technical Expert in Risk Management
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Design, Engineering
Projektbeschreibung
Only English-written CV will be accepted.
Please note that only selected candidates will be contacted.
For our Client in BASEL, we are looking for a MEDICAL DEVICE TECHNICAL EXPERT IN RISK MANAGEMENT, for a 6 MONTHS contract.
Duration: 18/06/2018 to 17/12/2018
Location: Basel
Workload: 90%
Major Responsibilities:
- 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.
Other Tasks:
* Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions
Candidate's Profile:
Linguistic background: English fluently
Work experience:
- At least 5 years of experience in device development of parenteral delivery systems, eg, drug/device combination products with main focus on medical devices for parenteral administration. The ideal candidate would have experience 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
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- General understanding of pharmaceutical development
- Good communication skills
For further details please contact Aleksandra Sztajerowska:
E-mail: (see below)
Please note that only selected candidates will be contacted.
For our Client in BASEL, we are looking for a MEDICAL DEVICE TECHNICAL EXPERT IN RISK MANAGEMENT, for a 6 MONTHS contract.
Duration: 18/06/2018 to 17/12/2018
Location: Basel
Workload: 90%
Major Responsibilities:
- 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.
Other Tasks:
* Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions
Candidate's Profile:
Linguistic background: English fluently
Work experience:
- At least 5 years of experience in device development of parenteral delivery systems, eg, drug/device combination products with main focus on medical devices for parenteral administration. The ideal candidate would have experience 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
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- General understanding of pharmaceutical development
- Good communication skills
For further details please contact Aleksandra Sztajerowska:
E-mail: (see below)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik