Description

In this role, you will lead the development of innovative drug delivery systems, collaborating with cross-functional teams to ensure projects meet quality and regulatory standards. Your expertise will drive the creation of state-of-the-art medical devices and packaging solutions.

Requirements

• •University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field
• •Minimum of 7 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment
• •Background in development of combination products for respiratory drug delivery
• •Experience in project leadership in a matrix organization
• •Strong organizational and communication skills
• •Experience with regulatory and quality standards and generation of documentation for regulatory agencies

Tasks

• •Plan and execute projects for evaluating and improving packaging materials and medical devices
• •Deliver projects on time, within quality standards and budget constraints
• •Collaborate with global cross-functional teams and external partners
• •Lead coordination of activities and information across functions
• •Apply expertise in Design Controls and Risk Management standards
• •Compile and maintain Design History Files and support design verification
• •Deliver submission-ready packages for regulatory bodies
• •Utilize engineering tools for robust design and device limitation analysis