We are seeking a highly experienced professional to join a strategic program focused on drug–device combination products, with a strong emphasis on autoinjector and safety syringe platforms.
You will play a hands‑on and strategic role in shaping the development, industrialization, and documentation of combination products. Your expertise will directly influence technical robustness, regulatory compliance, and risk‑based decision‑making across multiple development programs.
Key Responsibilities
* Lead the risk management workstream for autoinjector/safety syringe platform programs.
* Define platform boundaries and design space for device constituent parts across multiple molecules.
* Conduct impact assessments on quality system processes, design control documentation, and risk files.
* Update and harmonize documentation, including DHF, RMF, usability engineering, and platform‑specific files.
* Support evaluation and implementation of tools/software to improve design control and risk management efficiency.
* Collaborate with cross‑functional SMEs to ensure continuity across ongoing development projects.
* Provide guidance on regulatory expectations, design control, and combination‑product standards.
* Facilitate cross‑functional alignment and drive actionable decisions across technical teams.
Must‑Have Qualifications
* 8–15+ years of experience in drug–device combination product development.
* Strong expertise in autoinjectors and/or safety syringes.
* Hands‑on experience with risk management activities (FMEA, usability engineering).
* Deep knowledge of ISO 13485, ISO 14971, ICH Q8/Q9/Q10/Q12, FDA 21 CFR Part 4, EU MDR Article 117.
* Proven experience with design‑control documentation (DHF, RMF, regulatory files).
* Fluency in English.
* Experience in the pharmaceutical industry is mandatory.
* Strong communication, leadership, project management, and critical thinking skills.
Preferred Qualifications
* Knowledge of French (strong plus).
* Experience with pen injectors, on‑body delivery systems, or other parenteral platforms.
* Familiarity with documentation software/tools supporting design control and risk management.
* Understanding of IEC 62366 and human factors engineering.
* Experience with lifecycle management and post‑market activities for combination products.
#J-18808-Ljbffr