Job Description
A leading international life sciences organization is seeking a highly experienced Senior Expert in drug-device combination product development, with a strong focus on autoinjector platforms.
This role involves supporting the development, industrialization, and documentation of patient-centric combination products across multiple programs within a transversal device team.
1. Lead the risk management workstream for an autoinjector combination product platform from concept through commercialization.
2. Evaluate compliance with global standards and regulations including ISO 13485, ISO 14971, ICH Q9/Q8/Q10/Q12, and relevant EU directives.
3. Partner closely with cross-functional stakeholders to align design control and quality system expectations.
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