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Medical Device Technical Expert
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Design, Engineering
Projektbeschreibung
My client- one of the largest and centrally situated Pharma companies is recruiting for a Medical Device Technical Expert. THE ideal candidate would have at least 5-8 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.
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.
Requirement for the role are:
*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
*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
Other Tasks:
*Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
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.
Requirement for the role are:
*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
*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
Other Tasks:
*Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik