CSL Seqirus is seeking a Senior Engineer (Drug Delivery Lead) for their Bern, Switzerland location. The role involves leading the development of drug delivery systems through cross-functional collaboration while ensuring compliance with regulatory standards
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 Teams to deliver submission-ready packages for Notified Bodies and regulators.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a Senior Engineer (Drug Delivery Lead) for their Bern, Switzerland location. The role involves leading the development of drug delivery systems through cross-functional collaboration while ensuring compliance with regulatory standards.
Skills & Requirements
Must-have
drug delivery device development
combination products
medical devices
Design Controls and Risk Management
ISO 13485
ISO 14971
21 CFR 820
EU MDR requirements
Nice-to-have
project leadership in a matrix organization
respiratory drug delivery background
state-of–the-art drug delivery devices
Key Requirements
Minimum of 7 years in drug delivery device development
Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or related field