Description
Medical Device Technical Expert - R&D - Combination ProductsYou are looking for an exciting and significant work activity? If so, this is the right Job for you.
My client, a manufacturing leader in technical development and manufacturing of biologics located in Basel is looking for an Medical Device Technical Expert .
Location: Basel
Duration: 12 months, with potential extension
Main Task
- You are the ideal candidate, if you have at least 5 years of experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices for parenteral administration.
- Lead the preparation of Technical File and regulatory submission files to ensure timely approval of devices worldwide, especially in the US
- Ensure timely completion and quality of the assigned risk management files.
- Lead of specific risk management activities within projects, as agreed with project leaders
- Completion and Facilitate development 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, experience in generating DHF documentation.
Requirement for the role are:
- Perfect technical writing skills (e.g., Design Controls)
- 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
- Technical knowledge of primary containers development
- Knowledge of ISO13485, 21 CFR 820, ISO 14971
- Knowledge of medical device regulations, CE marking, 510 (k), 21 CFR 4 for combination products
- Communication skills
- Understanding of Human Factors Engineering and Risk management
- Understanding of clinical trial processes and requirements
- Understanding of pharmaceutical development
Other Tasks:
- Support preparation for Medical Device/Combination Product pre-registration documents and answer health authority questions.
Do we have attracted your attention for this Job, or maybe another similar position?
Please dont hesitate to send me your CV to
Im looking forward to hearing from you.
Sabina Keel
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.