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.
We are seeking a Field Action Specialist to join our UK & Ireland quality team!
This position is responsible for the coordination and processing of Field Actions issued by bioMérieux Global to ensure that UK customers are informed of issues with bioMérieux products that impact them and that appropriate actions are taken when necessary.
The role will also act as Vigilance support, ensuring that field actions are reported to the relevant authorities and that lines of communication with health authorities is maintained when the main vigilance contact is unavailable.
This position will require presence in our office in Basingstoke (hybrid working policy) and reports to the UK Quality Manager.
What will your responsibilities be within bioMérieux?
- Responsible for the implementation of Product Field Actions (FCA/FSCA/MAR/PSS/PRS) as necessary
- Determine whether Field Actions issued by global corporate sites are applicable to UK and Ireland customers.
- Interpret the requirements of requested Field Actions and process/coordinate accordingly (in collaboration with the marketing and customer service teams):
- Define the customer list targeted by the Field Action
- Manage the administration Field Action in outlook, Livelink, SAP and salesforce including creation of work orders & follow up
- Update the global follow-up files of Field Actions status.
- Interact with internal customer service teams, sales, marketing, supply chain, installed base and quality assurance departments to achieve end-to-end execution.
- Remotely interact on a regular basis with other bioMérieux subsidiaries and global functions to align execution strategies and corporate sites to receive additional input.
- Monitor Field Action progress through CRM dashboard to achieve defined due dates.
- Reporting vigilance activities to the local competent authorities and managing the requests for information from competent authorities in a timely manner during unavailability of the main vigilance contact.
- Communication with authorities, customers, third parties regarding regulatory compliance as needed.
Who are you?
- Bachelor of Science degree along with 3-5 years of experience in a clinical laboratory, Quality Management, Quality Control, Customer Service or equivalent experience
- Knowledge of compliance requirements, guidance documents and processes (local/regional).
- Knowledge of medical laboratory operation, equipment and products and/or quality management systems.
- Familiar with local regulatory agency organization, with company product profiles and technology.
- Excellent verbal and written communication skills
- Ability to analyze and use data to drive decisions.
- Excellent organizational and administrative skills.
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.