Quality & Regulatory Specialist
Location: Bromborough/Bootle
Schedule: Monday to Friday, flexible hours
Compensation: Competitive salary, please ask for more information
Benefits: Pension, Life Assurance, Private Healthcare
My client, a market leader within their industry, is looking for a Quality & Regulatory Specialist to support their QA department. This role has a large responsibility across the business and the company has benefited from excellent growth and progression. This is a great opportunity for an ambitious, experienced QARA professional to make an impact at a business within a great industry.
Role Description
* The Quality and Regulatory Specialist will work closely with the Quality Assurance Manager and assist in ensuring that all aspects of the Quality Management system remain effective.
* Working as part of the QARA Team to provide support and advice to Company departments in regulatory and quality assurance matters, as required.
* Assist in maintaining compliance with all applicable Quality standards regulatory and statutory requirements necessary to the continued business activities.
* Assist in ensuring that all documents and information relating to customer regulatory requirements are generated and available as required.
* Assist QARA Manager final sign off of Quality Control documentation as a 'Person responsible for regulatory compliance' in accordance with EU IVD Medical Device Regulation 2017/746.
* Ensure that all required aspects of business Quality Management Systems are implemented, controlled and managed in accordance with applicable International Quality Management standards.
* Work with Research and Development, and Quality Control staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements.
Skills and Qualifications
* Understanding the importance of Quality Management Standards (ISO 13485 and ISO 9001) and/or 'Medical device' regulatory affairs (albeit minimal). Knowledge of a QMS system, knowledge of ISO 13485 and IVDR, completed external and internal audits and CAPA's, and validation and verification experience.
* Life Science or related degree: Pass grade or above.
* Knowledge and understanding of diagnostic microbiology and diagnostic products.
* Experience of formal techniques of problem solving such as Risk based thinking, corrective and preventative actions, root cause analysis.
Company Information
As a business, our client is a true market leader within their industry with a strong presence across the UK. With a secure portfolio of clients, these roles provide a stable and secure opportunity in the present economic market.
In return for your commitment, my client offers a stable and secure career for technically motivated engineers. To apply please email your CV/resume to (url removed).
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