Description
Medical Device Technical Expert in Risk Management wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- 5+ years' experience in device development of parenteral delivery systems, such as drug/device combination products and DHF documentation
- Excellent technical writing skills coupled with proficiency in Product Design and Design for Manufacturing
- Good understanding of medical device regulations like FDA 21CFR 820 and EU Medical Device Directive as well as combination products
- Good technical knowledge of primary containers and auto-injector development
- General understanding of Human Factors Engineering, Risk, clinical trial processes and requirements of pharmaceutical development
- Languages: fluent English both written and spoken
Your tasks:
- Leading specific risk management activities within projects and ensuring timely completion and quality of assigned risk management files
- Ensuring compliance with ISO 14971 in all development projects assigned as well as with regulatory and normative guidelines focusing on medical device risk management
- Conducting and providing guidance on the use of risk analysis for Use, Products, Components and Processes
- Guiding internal and external functions on creating, reviewing and approving medical device Risk Management Files
- Applying FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects and author the documentation in the medical device risk management file
- Supporting DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions
Start: ASAP
Duration: 6MM+
Location: Basel, Switzerland
Ref.Nr.: BH12955
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