Research Scientist, Medical Devices, PhD

IVD Scientist
Type: 12 month FTC (has the potential to go permanent /to be reviewed at the end of the term)
Location: Liverpool initial (role will be moving to Deeside long term at their new modern site)
Hours: 8:30 - 16.30 Mon-Fri with some flex if needed (onsite) NB expenses will be provided when travelling to Liverpool *tunnel etc.
The Role: -
• To be responsible for carrying out existing and new product development activities as agreed under the general supervision of the line manager. All activities are to be conducted to the agreed scientific and regulatory standard or directives e.g. European IVDD and IVDR of the department and promptly reporting deviations from stated targets of performance.
• To be responsible, with minimum supervision, for conducting reviews of literature related to investigations being undertaken, conducting and, where necessary, enhancing experimental design, carrying out research studies, analysis of experimental data, reporting of studies in the form of a written report as per laboratory standards and ensuring raw materials are available as required for investigative studies.
• To be responsible for performing scientific and documentary activities related to regulatory requirements e.g. European IVDD and IVDR, to the agreed scientific and regulatory standards and promptly reporting deviations.
• To ensure products are designed and manufactured with sufficient robustness, so they do not compromise the health and safety of patients, users and third parties and attain the performance levels specified by the manufacturer.
• Supporting senior staff to provide a high standard of technical service and support including the investigation of customer complaints, production problems and assistance with validation studies.
• To be responsible for the collation of reference information relevant to all investigations and for the correct maintenance and updating of technical records in appropriate project files for allocated projects.
• To participate in laboratory project meetings where technical matters affecting current projects and present results are discussed.
• To provide assistance to senior staff in technical training for Sales and Marketing and laboratory personnel.
• To provide cover for Quality Control staff, as agreed between the Quality Control and R&D Managers when necessary.
• Prepare and present written reports and documents as directed, including the preparation and updating of Standard Operating Procedures, technical dossiers demonstrating product compliance with regulatory standards or directives, reports and documents for company policy and other meetings.
• To use specialised technical knowledge and skills to work on the development, documentation and evaluation of new products.
• To perform investigations related to the improvement of existing products and to investigate resolution of manufacturing issues.
• To apply a good understanding of QA, GMP, IVD Directive (IVDD) and Regulation (IVDR), ISO 9001 and ISO 13485 guidelines to Client Group products, allowing them to meet regulatory and market requirements and to generate significant profit for the company over their lifecycle.
The Person:-
• Will hold a degree in a relevant microbiology-based subject (the ideal Candidate will hold an MSc but not essential)
• The ideal Candidate will have experience working in an ISO 13485, IVDR (or related) - regulated industry.
• Experience in bacteriology with an emphasis on conventional techniques over molecular techniques
• Proven report writing skills
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