Infusion set expert

infusion Set Expert – Giving Set / Infusion Set Comparability (Contract)

We are supporting a client conducting gene therapy clinical trials who is preparing an EU regulatory submission and requires specialist expertise in infusion set comparability.

US clinical trials were completed using a pump and infusion set that underwent full in-use compatibility testing. However, this infusion set is not approved for use in the EU. An alternative pump and infusion set have been identified, and the client now requires expert support to assess comparability and provide a scientific and regulatory justification on whether a new in-use study can be avoided. An in-use study will run in parallel.

Key Responsibilities:

• Review and compare materials, components, and design features of two infusion/giving sets
• Assess material compatibility and potential impact on gene therapy delivery
• Provide scientific and regulatory justification on infusion set comparability
• Support EU regulatory submission documentation
• Advise cross-functional teams including regulatory and clinical stakeholders

Required Experience:

• Strong expertise in infusion sets, giving sets, or drug–device combination products
• Experience with material compatibility and in-use considerations
• Regulatory experience supporting EU and/or US submissions
• Background in biologics or advanced therapies (gene therapy experience preferred)

Contract Details:

• Start Date: Immediate
• Contract Length: 12 months
• Workload: Ad-hoc (approx. 10 hours per month