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 Position
This
Senior Scientist position
is 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.
Experience
The 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.