Senior Drug–Device Combination Documentation Expert

Position: Senior Drug–Device Combination Documentation Expert

Client: Biotech

Type: 12 months contract initially - full-time (40hours per week)

• Senior expert in drug–device combination product development, with a strong focus on autoinjector platforms.
• Strategic and hands‑on role covering development, industrialization, and documentation.
• Drives technical robustness, regulatory compliance, and risk‑based decision‑making across programs.

• Lead risk management activities for autoinjector combination products from concept to commercialization.
• Ensure compliance with global medical device and combination product regulations and standards (e.g., ISO 13485, ISO 14971, ICH Q8/Q9/Q10/Q12, 21 CFR Part 4, EU MDR Article 117).
• Collaborate with cross‑functional teams to align on timelines, design controls, and quality system requirements.
• Support selection and implementation of tools to enhance device documentation processes.
• Provide expert input on component selection, human factors, verification & validation, and device reliability.
• Prepare, review, and approve key device documentation (DHF, risk management files, usability engineering files, regulatory submissions).
• Contribute to continuous improvement of development processes and documentation practices.

• Strong experience in drug–device combination products, ideally with autoinjectors or parenteral delivery systems.
• Strong expertise in design control, risk management, DHF/RMF, technical and regulatory documentation.
• Solid knowledge of key international standards and regulations for combination products.
• Experience in global matrix environments and collaboration with external partners.
• Strong analytical, problem‑solving, communication, and influencing skills.
• Fluent in English (French is an advantage).
• Preferred: experience with injection systems (e.g., auto‑injectors, safety syringes, on‑body systems), human factors standards (e.g., IEC 62366), documentation tools, and lifecycle/post‑market management.

We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.