Regional Quality and Regulatory Affairs Director - Madrid, España - bioMérieux sa

bioMérieux sa

Empresa verificada

Madrid, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

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)