A world leader in the field of in vitro diagnostics
For almost 60 years and across the world, we have imagined and developed solutions to improve public health.
Today, our teams are spread across 44 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 looking for a Quality and Regulatory Affairs Director EME who will evolve within the quality department and report to the Senior VP of postmarket quality within a team of 12 co-workers.
What will be your responsibilities within bioMérieux?
1. Manage the Quality and Regulatory team in EME (7 clusters with a total of 23 subsidiaries, around 30 people, including 8 direct reports).
2. Be accountable for Regional Quality objectives and lead programs at the cluster and subsidiary levels to develop, implement, and continually improve systems ensuring customer requirements are integrated into company processes and services.
3. Execute Quality, Regulatory, Vigilance, and HSE strategies; ensure adherence to policies; and drive the implementation of regulatory processes at the project and program levels. Act as the point of contact for local Competent Authorities regarding FCA-FSCA management, incident decisions, and reporting.
4. Ensure an efficient Quality Management System compliant with corporate and external requirements (e.g., standards and regulations). Manage regulatory affairs in subsidiaries in coordination with Global RA.
Who are you?
* Master’s degree in Science, Engineering, Pharmacy, or Medicine.
* More than 7 years of experience in the field of IVDs/MDs within a European environment.
* Knowledge of quality standards (IVDR, MDSAP, ISO 13485, ISO 9001), vigilance, and regulatory requirements, guidance documents, and processes (local/regional).
* Strong leadership and communication skills, agility, and the ability to work independently and in a matrix organization.
* Experience working with local regulatory agencies such as ANSM, MHRA, HPRA.
* Experience in managing regulatory audits (ISO 9001, 13485, FDA, etc.).
* Willingness to travel as needed for meetings and training.
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