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Quality and Regulatory Affairs Specialist UKI

Location: Basingstoke, United Kingdom
Position Type: Unfixed Term

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

 

 

 

An exciting vacancy has arisen for a Quality and Regulatory Specialist. Reporting to the UKI Quality and Regulatory Manager, this position is primarily responsible for executing Quality and Regulatory tasks for the bioMérieux UK and Ireland subsidiary. Candidates need to be based near our Basingstoke office.

 

What will your responsibilities be at bioMerieux?

 

You will be assisting with the routine management of the Quality Management System including Document Control, Field Action Management, Quality Events, CAPA, Change Control, Audits and Management Review.

 

You will act as Document Controller for UKI and liaise with customers to establish and maintain quality agreements and answer general queries.

 

Assisting with regulatory responsibilities including administration of the MHRA registration portfolio, regulatory surveillance, UKCA/IVDR compliance and communicating with regulatory authorities, customers and third parties is essential.

 

You will be interacting with other bioMérieux subsidiaries, global functions and internal teams including global RA, Customer Services, Sales, Marketing, Supply Chain, Install Base and Quality Assurance departments to achieve end-to-end execution.

 

 

Who are you?

 

You will need a Bachelor of Science Degree in a Medical, Scientific, or Engineering subject.

 

1-3 years QA/RA experience working in a regulated environment with ISP certified quality management systems and knowledge and understanding of UK IVD and EU IVDR/MDR regulations, compliance requirements and guidance documents and processes is desirable.

 

Familiarity with local regulatory agency organizations (MHRA/HPRA), with company product profiles and technology is desirable and excellent verbal and written communications skills is essential.

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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