Job Title: Senior Documentation SpecialistLocation: BelgiumContract Length: until end of 2026 Rate: negotiableStart Date: ASAPHours: 40 hours per week (1.0 FTE) About the RoleWe are seeking a highly experienced Device Documentation Expert to join our client in their Device Services team as a Senior Expert in Drug–Device Combination Product Development. In this role, you will play a strategic and hands‑on part in shaping the development, industrialisation, and documentation of innovative drug‑device combination products — with a strong emphasis on autoinjector platforms.This is a key position where your expertise will directly influence product robustness, regulatory readiness, risk management, and cross‑functional decision‑making across multiple development programmes.What You’ll Be DoingLeading the risk management workstream for autoinjector drug–device combination products, from concept through to commercialisation.Ensuring full compliance with global standards and regulationsCollaborating closely with project managers and cross‑functional teams to meet design control expectations and project timelines.Supporting the assessment and selection of tools and software to improve device‑development documentation processes.Providing expert input on component selection, human factors engineering, verification & validation, and device reliability.Working with internal teams (Regulatory, Quality, Technical R&D, Clinical, Manufacturing) as well as external partners and suppliers.Preparing, reviewing, and approving device documentation, including DHFs, risk management files, usability documentation, and regulatory submissions.Contributing to continuous improvement initiatives for device development and documentation processes.What We’re Looking For10+ years’ experience in drug–device combination product development, ideally including extensive work on autoinjectors or other injectable delivery systems.Deep expertise in medical device and combination‑product documentation (DHF, risk management, design control, technical files).Strong working knowledge of relevant standards and regulations )ISO 13485, ISO 14971, ICH Q8 / Q9 / Q10 / Q12, 21 CFR Part 4, EU MDR Article 117)Excellent communication and stakeholder‑management skills within a global matrix environment.Fluent in English; French is a strong advantage.Interested? Apply now for immediate consideration or contact James Allen on +44 203 868 8607 – jallen@planet-pharma.co.ukWe are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.