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Medical Device Technical Expert - Risk Management
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Design, Engineering
Projektbeschreibung
Medical Device Technical Expert with expertise in Risk Management wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- 5 years of professionalism in device development of parenteral delivery systems enhanced by familiarity with DHF documentation
- Proficiency of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products
- In-depth experience with Product Design and Design for Manufacturing
- Good technical knowledge of primary containers development and autoinjector development
- Confidence of Human Factors Engineering and Risk management, as well as clinical trial processes and requirements an additionally pharmaceutical development in general
- Languages: fluent English both written and spoken
YOUR TASKS:
- Ensuring timely completion and quality of the assigned risk management files as well as leading specific risk management activities within projects
- Guaranteeing compliance with ISO 14971 in all development projects assigned and 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, additionally conducting and providing guidance on the use of risk analysis for Use, Products, Components and Processes
- Enforcing FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
START: 01/2018
DURATION: 6MM+
LOCATION: Basel, Switzerland
REF.NR.: BH12078
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- 5 years of professionalism in device development of parenteral delivery systems enhanced by familiarity with DHF documentation
- Proficiency of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products
- In-depth experience with Product Design and Design for Manufacturing
- Good technical knowledge of primary containers development and autoinjector development
- Confidence of Human Factors Engineering and Risk management, as well as clinical trial processes and requirements an additionally pharmaceutical development in general
- Languages: fluent English both written and spoken
YOUR TASKS:
- Ensuring timely completion and quality of the assigned risk management files as well as leading specific risk management activities within projects
- Guaranteeing compliance with ISO 14971 in all development projects assigned and 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, additionally conducting and providing guidance on the use of risk analysis for Use, Products, Components and Processes
- Enforcing FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
START: 01/2018
DURATION: 6MM+
LOCATION: Basel, Switzerland
REF.NR.: BH12078
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik