In this position, you will lead the technical development of packaging and/or drug delivery systems from early phase activities up to commercialization and production scale up. Your responsibilities include: - 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 - Leading the collaboration with external development partners - Monitor work progress according to plan - Monitor, support and challenge technical development as well as test and verification work - Monitor development and implementation of manufacturing processes
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
Global Pharma Company.
If you are interested then kindly send your resume to: email@example.com
- Several 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 - General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements
Bachelor’s or Master degree in Packaging Science/Engineering or Mechanical Engineering
English : Very good