Senior Scientist

1 day ago

Galway, Ireland Hrm Full time

Our client is a world leader in the in-vitro diagnostics (IVD) sector, dedicated to developing innovative technologies that provide critical health information.This role is based at a state-of-the-art R&D and manufacturing facility where teams work on the entire product lifecycle, from initial concept and development to commercial support and post-market surveillance for a global portfolio of diagnostic products.The PositionThisSenior Scientist positionis a key role within the Technical Product Support (TPS) team, providing high-level scientific expertise for a range of lateral flow medical devices.The position supports the Quality Organization in meeting global regulatory requirements for products on the market.Key responsibilities of this position include:Applying deep scientific knowledge to support the post-market analysis of lateral flow assay performance.Collaborating with the Quality team to ensure compliance with IVDR and IVDD regulations for Post Market Performance Follow-up (PMPF).Planning, organizing, and conducting scientific investigations to resolve complex technical problems.Creating and releasing critical regulatory documents, including State of the Art (SOTA) reports, Clinical Performance Reports (CPR), and Scientific Validity Reports (SVR).Analyzing data from multiple sources, formulating conclusions, and determining future experimental plans.Providing technical leadership and guidance on PMPF requirements to cross-functional teams and multiple sites.Developing training programs and standard operating procedures to ensure all activities comply with regulatory and quality standards.Supporting external audits and certification activities by preparing documentation and responding to findings.ExperienceThe ideal candidate will be a proactive and analytical scientist with a strong background in supporting IVD products in a regulated environment.The qualifications and experience required are:A BS/MS degree in a Life Science discipline such as Biology, Biochemistry, or Biomedical Science.Proven experience in Post Market Surveillance requirements within the IVD/Medical devices industry.Strong technical writing skills with direct experience authoring regulatory documents.Working knowledge of statistical analysis.A strong understanding of the design, development, and manufacture of in vitro diagnostic tests.Excellent analytical, quantitative, and problem-solving skills.Preferred qualifications include:Direct knowledge and experience with IVDR requirements.A technical background in device and assay development.5+ years of experience in the IVD/medical devices industry with a strong Molecular and Biochemical background.Proven skills in conducting root cause analysis and technical troubleshooting.To discover more about this opportunity, please apply online or contact Lewis Murray on for a confidential discussion.

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