Regional Quality and Regulatory Affairs Director Eme

il y a 4 semaines


Villeurbanne, France bioMérieux Temps plein

**Regional Quality and Regulatory Affairs Director EME**:
Location: Marcy l'Etoile, France
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 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 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)



  • Villeurbanne, France bioMérieux Temps plein

    **Clinical Affairs Senior Manager Immunossays**: Location: Marcy l'Etoile, France Position Type: Unfixed Term Job Function: Clinical Affairs A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to...


  • Villeurbanne, France bioMérieux Temps plein

    **Clinical Affairs Senior Manager Immunossays**: Location: Marcy l'Etoile, France Position Type: Unfixed Term Job Function: Clinical Affairs A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to...

  • Regional Director

    il y a 2 semaines


    Villeurbanne, France PPG Industries Temps plein

    PPG, the French leader in the sale of paints and paint products to professionals, under the brand name Comptoir Seigneurie Gauthier has a store network of 275 stores throughout the country. We are looking for a Senior Sales Manager located near Lyon (69). As a **Regional Director (M/W) **you will report to the National Director and you will manage a team...


  • Villeurbanne, France ALSTOM Temps plein

    Req ID:406666 We create smart innovations to meet the mobility challenges of today and tomorrow. We design and manufacture a complete range of transportation systems, from high-speed trains to electric buses and driverless trains, as well as infrastructure, signalling and digital mobility solutions. Joining us means joining a truly global community of more...


  • Villeurbanne, France bioMérieux sa Temps plein

    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...

  • Cdd 4 Mois

    Il y a 2 mois


    Villeurbanne, France seqens Temps plein

    **Famille / Sous-famille d'emploi**: - Quality & Regulatory - Regulatory Affairs **Type de contrat**: - Contrat à durée déterminée **Durée du contrat (Mois)**: - 4 **Intitulé du poste**: - CDD 4 mois - Assistant(e) Qualité client H/F **Contexte du poste**: - Au sein du service Qualité Clients vous serez en charge de réceptionner, gérer et...

  • Supply Chain Intern Eso

    il y a 2 semaines


    Villeurbanne, France Galderma Temps plein

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • Inern Quality

    il y a 1 semaine


    Villeurbanne, France Henkel Temps plein

    At Henkel, you can build on a strong legacy and leading positions in both industrial and consumer businesses to reimagine and improve life every day. If you love challenging the status quo, join our community of over 50,000 pioneers around the globe. Our teams at Henkel Adhesive Technologies help to transform entire industries and provide our customers with...

  • Civil Design

    Il y a 2 mois


    Villeurbanne, France Renewable Energy Grid Solutions Temps plein

    **Job Description Summary**: Gris System Integration (GSI) is in charge of delivering turnkey high voltage substation project involving all technologies. These integrated solutions enable large scale electrification and integration of green, sustainable renewable energy with a great sense of purpose Within GSI South Europe, the Civil Work Leader is...


  • Villeurbanne, France French Selection UK Ltd Temps plein

    FRENCH SELECTION (FS) Division Chief Financial Officer H/F Location: Macon **Salary**: region of 95000€ per annum Ref: 775MC A well-established importer and distributor part of a larger multinational group of companies. Main duties: Play a key role in French financial management, ensuring accurate reporting and enhancing systems for seamless...


  • Villeurbanne, France DAVRICOURT Temps plein

    **À propos**: DAVRICOURT recrute pour SYMBIO ! Équipementier de nouvelle génération, SYMBIO conçoit des systèmes de piles à hydrogène qui peuvent être intégrés dans plusieurs types de véhicules électriques (utilitaires, bus, poids lourds, bateaux). Détenu à parts égales par les groupes Michelin et Faurecia, SYMBIO est en hyper-croissance et...


  • Villeurbanne, France Groupe Seb Temps plein

    **Job Type **:Permanent contract | Full-time | Unbefristet **City **:Parsippany **Company description**: - Tefal, T-Fal, Krups, Lagostina, Rowenta, Moulinex, SUPOR, WMF, Arno, Emsa, All-CladThese brands are part of the daily life of millions of consumers in more than 150 countries. With 33,000 employees and over €8,1 b sales annually, Groupe SEB is the...


  • Villeurbanne, Auvergne-Rhône-Alpes, France bioMérieux Temps plein

    A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 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...

  • Technical Director

    Il y a 2 mois


    Villeurbanne, France The Tiny Digital Factory Temps plein

    Créé en 2015 par des vétérans du jeu vidéo et basé à Lyon et Montréal, The Tiny Digital Factory est un studio de création de jeux vidéo spécialisé dans le sport automobile. Fort d'une trentaine de collaborateurs, le studio édite depuis 2020 ses propres jeux mobiles et collabore avec des éditeurs sur des jeux PC et Web3. Dans ce cadre, nous...

  • Compliance Engineer

    Il y a 2 mois


    Villeurbanne, France Focal Temps plein

    Vervent Audio Holding is a manufacturer and distributor of high-end and luxury audio equipment. The Holding has over 40 years of experience in designing and manufacturing audio equipment such as home or professional studio speakers, headphones, car speakers and amplifiers. Vervent Audio Holding is the holding company of Focal JMLab, world leader in...


  • Villeurbanne, France bioMérieux Temps plein

    A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 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...


  • Villeurbanne, France ALSTOM Temps plein

    Req ID:420333 We create smart innovations to meet the mobility challenges of today and tomorrow. We design and manufacture a complete range of transportation systems, from high-speed trains to electric buses and driverless trains, as well as infrastructure, signalling and digital mobility solutions. Joining us means joining a truly global community of more...


  • Villeurbanne, France Cisco Systems Temps plein

    Cyber Vision Job description - Description - As a member of the IOT BU engineering team you will participate in the design and development of Cisco Cyber Vision which is a cloud based comprehensive asset inventory, network monitoring and threat detection solution for industrial networks. - Our solution is developed with the following technical stack:-...


  • Villeurbanne, Auvergne-Rhône-Alpes, France ALSTOM Temps plein

    Req ID:426446At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than colleagues lead the way to greener and smarter mobility...


  • Villeurbanne, France ALSTOM Temps plein

    Req ID:426446 At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than 80 000 colleagues lead the way to greener and smarter...