Packaging / Medical Device Development Project
vor 21 Stunden
For one of our pharma clients in Basel we are currently looking for a Packaging/Medical Device development Project Leader for a 12 Months contract.
**Responsibilities**:
- Thorough project planning and execution
- Leading the definition of product requirements for packaging, medical devices, delivery systems, e.g. drug/device combination products in which the device is generally already registered but sometimes to be developed
- Managing the collaboration with internal development partners and stakeholders
- Provide primary packaging and device expertise in a broader cross-functional drug product development team
- Supporting and coordinating the manufacturing of clinical material and the production scale up
**Requirements**:
- Bachelor’s or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education.
- 7 years’ experience in leading device development technical teams in a similar area
- Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)
- Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
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