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| Job description | |
| Purpose This is a laboratory based position reporting to the European Clinical Research & Operations Leader with specific assignments to evaluate, execute and report on the safety and efficacy of new or modified in-vitro diagnostic devices. Responsible for the understanding of product design, function, as well as applying quality and regulatory standards. Operation of multiple instrument platforms and utilization of technical/scientific judgment to resolve technical issues. Interfacing with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products, and processes in the development and monitoring of BD products. Main Responsibilities 1. Compilation and management of budgets. 2. Identification and purchasing of suitable equipment. 3. To ensure compliance with relevant regulations such as GLP and ISO 9001 as well as understanding of ISO 15189. 4. Maintenance of all laboratory equipment/reagents test systems and documentation to strategically align with needs of project teams and the business. 5. Administration of National External QC schemes, to include clinical chemistry, lipids, blood gases, haematology and coagulation. 6. Perform clinical evaluations for clinical trials in compliance with regulatory requirements. 7. Creation and implementation of protocols and reports to include statistical evaluation, conclusions and recommendations. 8. Development and validation of analytical tests in accordance with established procedures. 9. Customer liaison and technical support. Aid / co-ordinate customer complaint investigations and provide written reports where necessary. 10. Technical support to Sales, Marketing and manufacturing projects as required. Provide assistance in customer visits. Create and define training programs and support business services. 11. Co-ordination for investigative work undertaken by external partners. 12. Maintain an understanding of current practices in laboratory medicine by the study of technical literature, attendance at continuing education courses, symposia, product expositions and customer visits. Monitors trends in laboratory methodologies that could affect the business. Utilizes knowledge to recommend new projects and influence new projects. 13. Member of group of technical associates (ETF) resolving customer concerns in the EU and EMA market. 14. Interface with R&D, marketing, Manufacturing, Corporate Statistics, QA and Regulatory to insure the successful and timely completion of projects. 15. Strong commitment to quality and continuous improvement. 16. Actively supports and implements all departmental (MSACO), divisional (BD PAS) and company (BDX) policies and procedures. Person Specification 1. Degree in Life Sciences. Clinical background a distinct advantage. 2. Minimum 3 years in a clinical laboratory or research laboratory environment 3. Self motivated team player with good verbal and written communication skills. 4. Computer literate. Intermediate level in Excel/word/PowerPoint etc 5. Ability to work autonomously, and be capable of independently generating, prioritising and completing work. 6. Experience and ability to work in a matrix organization 7. Excellent communication, presentation and organisational skills 8. Self motivated with a desire for self-development 9. An ability to show initiative 10. The successful candidate should be dynamic, with excellent interpersonal skills, clear and precise communication skills and the strength to propose and apply actions. 11. Strong supporter of the core BD values. Experience • Experience in Clinical Laboratory disciplines (chemistry, haematology, coagulation, etc.) and operation of multiple instrument platforms. • Medical products experience preferred. Knowledge of specific procedures/practices: • Knowledge of clinical laboratory procedures and understanding of applicable regulatory practices. Complexity of duties: • Formulates protocols and executes scientific investigations in areas of considerable scope and complexity. Explores, identifies, and recommends solutions, concepts and principles. • Participates in development of methods, techniques and evaluation criteria for projects and programs. |
Job Type:
Permanent
Location:
United Kingdom Cumbria
Salary:
[n/a]
Date available:
n
Experience Skills:
Qualified
Company:
BD
Company Description:
[n/a]
Company Website:
[n/a]
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