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 Were Looking For:
Must Haves
* Masters degree in a relevant scientific or engineering field (or equivalent experience).
* 48+ 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.