Senior Documentation Specialist

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

We 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.