Regional Quality and Regulatory Affairs Director
3 settimane fa
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 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 will report to the Senior VP of postmarket quality within a team of 12 co-workers.
**What will be your responsibilities within bioMérieux?**
- Be responsible for the management of Quality and Regulatory team in EME (7 clusters with a total of 23 subsidiaries = around 30 people - 8 direct reports)
- Be accountable for Regional Quality objectives, lead programs at clusters & subsidiaries levels for developing, implementing and continually improving systems to ensure customer requirements are implemented into company processes and services provided
- Execute Quality, Regulatory, Vigilance and HSE strategies; ensure adherence to policies and drive implementation of the regulatory processes as planned at Project/Program level. You will be the point of contact for the local Competent Authorities for the management of FCA-FSCA, Incident decisions and reporting
- Ensure an efficient Quality Management System is established in compliance with Corporate and external requirements (e.g. applicable standards and regulations, Distributors management).
- Be responsible of Regulatory Affairs in the subsidiaries, in coordination with Global RA
**Who are you?**
- Master’s degree in Science or Engineering, pharmacist or physician
- More than 7 years of experience in the field of IVDs/MDs in an European environment
- Knowledge of quality (IVDR, MDSAP, ISO 13485 / ISO9001 and/or local regulations if appropriate), vigilance and regulatory requirements, guidance documents and processes (local/regional)
- High leadership and communication skills, agility and ability to work in a matrix organization both independently and in a team environment
- Ability to work with local regulatory agencies** **(ANSM, MHRA, HPRA )
- Experience in participation in the management of regulatory audits (i.e. ISO 9001, 13485, FDA, etc.)
Mobility: Travel as needed (external meetings with the local and corporate teams, trainings)
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