Clinical device lead

This is a contract of 1 year as a Consultant.

Location : Braine l'Alleud

Your Responsibilities:

• Lead and manage the Clinical Drug Delivery Devices (CDDD) sub-teams for selection and assessment of devices.
• Provide expert technical support to clinical teams and trial sites on drug delivery devices.
• Analyze and validate device specifications (e.g., needle size, tubing length, flow rate) to ensure compatibility with drug products.
• Support technical assessments of devices selected by CROs.
• Address and process Change Requests from clinical sites (e.g., device availability or new site activation).
• Act as the subject matter expert (SME) for all device-related queries during clinical trial lifecycles.
• Ensure timely documentation and updates of device decisions and changes in the CDDD database.
• Collaborate cross-functionally with QA, RA, Safety, and SME teams to meet trial timelines.

Profile We're Looking For:

Must-Haves

• Master's degree in a relevant scientific or engineering field (or equivalent experience).
• 4-8+ years of experience with injection systems (syringes, pumps, needles, infusion lines, etc.) in clinical or technical contexts.
• Strong technical understanding of medical devices and drug-device compatibility.
• Experience in clinical trials setup and device support.
• Thorough knowledge of medical device regulations:
• EU MDR
• 21 CFR Part 820
• ISO 13485
• GxP (GMP/GCP)
• Excellent analytical and problem-solving skills to assess technical specifications and ensure product compatibility.
• Solid project management and risk management capabilities.
• Excellent written communication and documentation skills.
• Strong autonomy, responsiveness, and attention to detail.

Nice-to-Haves

• Experience supporting clinical operations or sites in device selection.
• Knowledge in QA or regulatory affairs in combination with technical skills.
• Experience with drug-device compatibility testing and materials of contact assessments.