Expert in Drug–Device Combination Product Development

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 is a strategic and hands-on role within a transversal device team, supporting the development, industrialization, and documentation of patient-centric combination products across multiple programs.

Key Responsibilities

• Lead the risk management workstream for an autoinjector combination product platform from concept through commercialization
• Ensure compliance with global standards and regulations including ISO 13485, ISO 14971, ICH Q9/Q8/Q10/Q12, 21 CFR Part 4, EU MDR Article 117
• Partner closely with cross-functional stakeholders to align with design control and quality system expectations
• Support evaluation and selection of documentation and development software tools
• Provide expert input on component selection, human factors, V&V, and device reliability
• Prepare, review, and approve key device documentation (DHF, RMF, usability files, regulatory submissions)
• Contribute to continuous improvement of combination product development processes

Required Experience & Skills

• 15+ years in drug–device combination product development (autoinjector experience strongly preferred)
• Proven expertise in design control, risk management, DHF/RMF, technical and regulatory documentation
• Strong knowledge of relevant international standards and regulatory frameworks
• Fluent English required; French is a strong advantage
• Comfortable working in a global matrix environment with external partners
• Strong analytical mindset, communication, and cross-functional influence

Nice to Have

• Experience with injection systems (pen injectors, safety syringes, on-body delivery)
• Familiarity with documentation/data integrity tools
• Knowledge of IEC 62366 (human factors engineering)
• Lifecycle management and post-market surveillance exposure