Regional Quality And Regulatory Affairs Director Firenze

Regional Quality And Regulatory Affairs Director
Firenze
Toscana, Firenze

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)