Our client amajor multinational is recruiting for aSenior Scientistto join their growing team inGalway.
This is an initial12-month contract working four days on site and one day remotely.
TheSenior Scientistwill be member of the Technical Product Support (TPS) team providing solutions to a wide range of lateral flow medical devices.
Responsibilities of a Senior Scientist (Full job description available on request): Apply scientific knowledge to lateral flow assays and devices to provide product composition data on devices shipped to meet global regulatory requirements.
Collaborate with quality team on ensuring IVDR and IVDD regulations for Post Market Performance Follow-up (PMPF) are met.
Create and release State of the Art (SOTA) documents, Clinical Performance Reports (CPR) and Scientific Validity Reports (SVR) in line with IVDR and IVDD requirements.
Maintain a high level of professional expertise by staying current with scientific and industry literature, technologies and products.
Develop and maintain internal and external customer contacts to maintain technical knowledge as required to accomplish objectives.
Create and maintain training programs and operating procedures that ensure all PMPF activities meet regulatory guidelines and comply with the Quality System.
Provide technical support and guidance on PMPF requirements to the Scientific & Technical organization across multiple sites in lateral flow and invitro diagnostic devices.
Ideal background: BS/MS degree in any of the following disciplines Science / Biologics / Bio Med Technical writing and reporting skills and experience.
Knowledge of the manufacture and design of in vitro diagnostic tests.
Skills and knowledge in statistical analysis.
Strong analytical and quantitative skills.
Knowledge and experience in IVDR requirements particularly in relation to Environmental requirements Technical background in device and assay development 5+ years of invitro diagnostics / medical devices industry with a strong Molecular and Biochemical background.
For a confidential discussion on thisSenior Scientistrole and more information, please contactSarah Flynn.
Skills: IVDR ASSAYS Scientific Validity Reports