Plan, coordinate, and execute Combination Product development projects (drug-device combination products) while ensuring alignment with project timelines, quality requirements, and budget objectives
Develop and maintain technical documentation, including Design Control and Risk Management deliverables, in compliance with regulatory and quality standards
Support the design, customization, qualification, optimization, and technology transfer of drug delivery devices for respiratory, subcutaneous, and intravenous applications
Collaborate closely with cross-functional teams across R&D, Technical Operations, Quality, and Manufacturing to ensure successful project execution and effective knowledge transfer
Contribute to the continuous improvement of Combination Product development processes, procedures, and technologies while keeping up to date with industry trends, regulations, and best practices
Profile
Master's degree or PhD in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline
Several years of experience in the pharmaceutical, medical device, or Combination Product industry, or within a comparable research environment
Strong expertise in drug delivery systems, Combination Products, Design Control, and Risk Management methodologies
Proven experience in preparing technical, quality, and regulatory documentation to support product development and regulatory submissions
Excellent communication and organizational skills, with the ability to work independently and effectively within cross-functional international teams; fluent in English (written and spoken)