Device Documentation Expert
We are seeking a highly experienced professional to join our Device Transversal Services team as a Device Documentation Expert, specializing in drug–device combination products, with a strong focus on autoinjector platforms.
In this strategic and hands-on role, you will influence the development, industrialization, and documentation of complex combination products across multiple development programs. You will be responsible for ensuring technical robustness, regulatory compliance, and strong risk‑based decision‑making.
Key Responsibilities
* Lead the risk management workstream for the autoinjector platform, from concept through commercialization.
* Ensure full compliance with relevant standards and regulations, including ISO 13485, ISO 14971, ICH Q8/Q9/Q10/Q12, 21 CFR Part 4, and EU MDR Article 117.
* Collaborate closely with the platform project manager and cross‑functional teams to maintain alignment with timelines, design control expectations, and internal quality system processes.
* Support the evaluation and selection of software tools to optimize device‑development documentation.
* Provide expert guidance on component selection, human factors engineering, verification and validation (V&V), and device reliability.
* Work effectively with internal teams (Regulatory, Quality, Technical R&D, Clinical, Manufacturing) as well as external partners.
* Prepare, review, and approve device documentation, including Design History Files (DHF), Risk Management Files (RMF), usability engineering documentation, and regulatory submissions.
* Contribute to the continuous improvement of drug–device development processes and documentation practices.
Required Qualifications
* At least 8-10 years of experience in drug–device combination product development, ideally with strong exposure to autoinjectors or parenteral delivery systems.
* Demonstrated expertise in medical‑device and combination‑product documentation (DHF, RMF, design control, regulatory files including Technical Files).
* Deep understanding of the following standards and regulatory frameworks:
* ISO 13485 – Quality Management Systems for Medical Devices
* ISO 14971 – Risk Management for Medical Devices
* ICH Q8, Q9, Q10, Q12 – Pharmaceutical Quality and Risk Management
* 21 CFR Part 4 – cGMP for Combination Products
* EU MDR Article 117 – Notified Body Opinion
* Fluent in English; French is a strong advantage.
* Experience working in a global matrix environment and collaborating with external development and manufacturing partners.
* Strong analytical, problem‑solving, communication, and cross‑functional influencing skills.