Senior Engineer (drug Delivery Lead)

CSL Limited

Bern, Switzerland
Hybrid (3 days in-office presence required)
Drug delivery systems development
Combination products and medical devices
Design controls and risk management
CSL Limited is seeking a Senior Engineer (Drug Delivery Lead) to oversee the development of drug delivery systems, requiring significant cross-functional collaboration and leadership. The role is based in Bern, Switzerland, and necessitates a minimum of seven years of relevant experience in drug delivery device development within a regulated environment

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: 85

CSL Limited is seeking a Senior Engineer (Drug Delivery Lead) to oversee the development of drug delivery systems, requiring significant cross-functional collaboration and leadership. The role is based in Bern, Switzerland, and necessitates a minimum of seven years of relevant experience in drug delivery device development within a regulated environment.

Skills & Requirements

Must-have

  • Drug Delivery Systems development
  • Combination products and medical devices
  • Design Controls and Risk Management
  • EU MDR requirements
  • Design History Files
  • Submission-ready packages

Nice-to-have

  • Cross-functional interaction
  • Global internal expert teams
  • State-of-the-art drug delivery devices
  • Matrix organization experience

Key Requirements

  • Minimum of 7 years in drug delivery device development
  • Masters or PhD in Biomedical Engineering or related field
  • Experience with regulatory and quality standards

Work Rights

Not specified

Tailored Resume

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