Description
Medical Device Technical Expert with autoinjector knowledge wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- 8+ years of experience in device development of parenteral delivery systems with main focus on medical devices for parenteral administration, specifically autoinjectors
- Experience generating DHF documentation, including design input requirements, technical specifications, design verification, design validation and design transfer
- Excellent technical writing skills (e.g., design controls) with profound understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and combination products (US)
- Experience with autoinjector development
- Technical knowledge of primary container development, product design and design for manufacturing
- Languages: fluent English both written and spoken
Your tasks:
- Creating Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems
- Authoring and reviewing DHF documents
- Ensuring quality and compliance to regulations of the DHF elements of the assigned projects
- Consulting on the development of medical devices and combination products
- Ensuring device design development in compliance with the regulations
- Supporting DRA (Drug Regulatory Affairs) to prepare medical device/combination product pre-registration documents
Start: ASAP
Duration: 5MM+
Location: Basel, Switzerland
Ref.Nr.: BH10576
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