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Quality & Regulatory Affairs Specialist - 12 Month Contract

Location: Basingstoke, United Kingdom
Position Type: Fixed-Term
Job Function: Regulatory Affairs

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 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.

 

 

 

Fixed Term 12 Months Contract

 

Reporting to the UK Quality/Regulatory Manager, this position is responsible for the management of regulatory tasks for the UK/Ireland cluster. This includes acting as a point of contact for regulatory matters and managing integration of UKCA requirements for In Vitro Diagnostics (IVD) to ensure compliance by the relevant deadlines. The position will also have the responsibility of managing the MHRA registration portfolio and conducting local regulatory surveillance activities.

 

This position will require presence in our office in Basingstoke (hybrid working policy)
 

What will your responsibilities be within bioMérieux?

  • Management of UK Conformity Assignment (UKCA) implementation project.
  • Take ownership of the MHRA IVD registration portfolio including new product registrations, removal of discontinued products, updates of documentation etc.
  • Compile various regulatory applications to ensure continued supply of diagnostics to the UK and Ireland.
  • Conduct Regulatory surveillance activities to monitor changing UK/Ireland regulations.
  • Support product launch activities.
  • Provide Regulatory support to the bioMérieux Third Party Product (TPP) portfolio to ensure continued supply.
  • Interact with other bioMérieux subsidiaries, global functions and internal teams including global RA, Customer Services, Sales, Marketing, Supply Chain, Installed Base and Quality Assurance departments to achieve end-to-end execution.
  • Communication regulatory authorities (MHRA/HPRA), customers, third parties regarding regulatory compliance as needed.
  • Support for other team members during absence as needed.

 

Who are you?

  • Bachelor of Science Degree in Life Sciences
  • 3-5 years QA/RA experience working in a highly regulated environment with ISO certified quality management systems.
  • Knowledge and understanding of UK IVD regulations, compliance requirements, guidance documents and processes.
  • Knowledge and understanding of EU IVDR/MDR
  • Familiar with local regulatory agency organizations (MHRA/HPRA), with company product profiles and technology.
  • Excellent verbal and written communication skills
  • Highly organized with the ability to analyze and use data to drive decisions.

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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