Job Title: Senior Documentation Specialist
Location: Belgium
Contract Length: until end of 2026
Rate: negotiable
Start Date: ASAP
Hours: 40 hours per week (1.0 FTE)
About the Role
We 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 Doing
* Leading the risk management workstream for autoinjector drug–device combination products, from concept through to commercialisation.
* Ensuring full compliance with global standards and regulations
* Collaborating 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 For
* 10+ 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.uk
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