Senior Drug–Device Combination Documentation Expert

Position: Senior Drug–Device Combination Documentation Expert

Location: On-site - Braine, Belgium

Client: Biotech

Type: 12 months contract initially - full-time (40hours per week)

About the Role

• Senior expert in drug–device combination product development, with a strong focus on autoinjector platforms.
• Strategic and hands-on role covering development, industrialization, and documentation.
• Drives technical robustness, regulatory compliance, and risk-based decision-making across programs.

Main Responsibilities

• Lead risk management activities for autoinjector combination products from concept to commercialization.
• Ensure compliance with global medical device and combination product regulations and standards (e.g., ISO 13485, ISO 14971, ICH Q8/Q9/Q10/Q12, 21 CFR Part 4, EU MDR Article 117).
• Collaborate with cross-functional teams to align on timelines, design controls, and quality system requirements.
• Support selection and implementation of tools to enhance device documentation processes.
• Provide expert input on component selection, human factors, verification & validation, and device reliability.
• Prepare, review, and approve key device documentation (DHF, risk management files, usability engineering files, regulatory submissions).
• Contribute to continuous improvement of development processes and documentation practices.

Main Requirements

• Strong experience in drug–device combination products, ideally with autoinjectors or parenteral delivery systems.
• Strong expertise in design control, risk management, DHF/RMF, technical and regulatory documentation.
• Solid knowledge of key international standards and regulations for combination products.
• Experience in global matrix environments and collaboration with external partners.
• Strong analytical, problem-solving, communication, and influencing skills.
• Fluent in English (French is an advantage).
• Preferred: experience with injection systems (e.g., auto-injectors, safety syringes, on-body systems), human factors standards (e.g., IEC 62366), documentation tools, and lifecycle/post-market management.

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

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.

• www.planet-pharma.com