This position is no longer open for applications

Quality & Regulatory Specialist

Bromborough/Bootle

Monday to Friday, flexible hours

Competitive salary, please ask for more information

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). Having knowledge of a QMS system, knowledge of ISO 13485 and IVDR, completed external and internal audits and CAPA’s, and has 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 benw@hunterselection.co.uk 

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