Quality & Regulatory Specialist

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 analysisCompany 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

If you are interested in this position please click 'apply'.

Hunter Selection Limited is a recruitment consultancy with offices UK wide, specialising in permanent & contract roles within Engineering & Manufacturing, IT & Digital, Science & Technology and Service & Sales sectors.

Please note as we receive a high level of applications we can only respond to applicants whose skills & qualifications are suitable for this position. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business