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CSL Behring is seeking a Senior Engineer (Drug Delivery Lead) in Bern, Switzerland, to oversee the development of drug delivery systems through extensive cross-functional collaboration. The ideal candidate will possess significant experience in drug delivery device development, particularly in the pharmaceutical sector, and will be responsible for project leadership, compliance with regulatory standards, and ensuring timely execution of projects.
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Job Summary
Responsible for bringing new Drug Delivery Systems through the development process with considerable cross-functional interaction.
Application of expertise in Design Controls, Risk Management, EU MDR requirements, and compilation of Design History Files.
Provide leadership to Project Team to deliver submission-ready packages for Notified Bodies and regulators.
Matching Summary
Match Score: 75
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CSL Behring is seeking a Senior Engineer (Drug Delivery Lead) in Bern, Switzerland, to oversee the development of drug delivery systems through extensive cross-functional collaboration. The ideal candidate will possess significant experience in drug delivery device development, particularly in the pharmaceutical sector, and will be responsible for project leadership, compliance with regulatory standards, and ensuring timely execution of projects.
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Skills & Requirements
Must-have
drug delivery systems development
combination products and medical devices
Design Controls and Risk Management
ISO 13485, ISO 14971, 21 CFR 820
EU MDR requirements
Design History Files compilation
design verification and validation
submission-ready packages for regulators
Nice-to-have
cross-functional team leadership
collaboration with global expert teams
state-of-the-art drug delivery devices
robust designs and device limitations
matrix organization project leadership
Key Requirements
Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering
Minimum of 7 years in drug delivery device development
Relevant pharma industry experience or other highly regulated environment