Cdi - Product Regulatory Affairs Specialist - F/m

il y a 6 jours

Lyon, 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 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.

**What are your missions?**

In the CARAT department (Clinical Affairs and Regulatory Affairs Team), in the Regulatory Affairs Product team, you will define, develop and implement regulatory strategies for the successful and fast worldwide registration of IVDs in a flex position for the Clinical Microbiology and Immunology units. The job responsibility includes, overseeing regulatory approvals for Europe (CE Marking with our notified body), the US (FDA), and China (NMPA).

Lastly, you will ensure that relevant corporate regulatory processes are established, continuously improved and followed.

Main Accountabilities:

- Ensure timely execution of regulatory submissions in line with company strategies,
- Provide expertise in translating regulatory requirements into practical, workable plans,
- Validate product labels, instructions for use, advertising and/or promotional materials,
- Assist in drafting and validating answers to questions from regulatory authorities; monitor progress and escalate delays, problems as necessary
- Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team, supported by an efficient regulatory watch,
- Understand, investigate regulatory history of similar products in order to assess regulatory implications for new products

**What is your profile?**
- Strong scientific background (e.g. Bachelor, or Master’s Degree),
- Knowledge and understanding of regulatory processes with minimum 2 years of practice in the field of IVD’s/MDs in an international environment,
- Good understanding of QMS requirements (design and change control processes), as well as of audits/inspections.

Soft skills:

- Ability to work in an international environment,
- Strategic and analytical thinker, problem solver, and planner with excellent organizational skills,
- Capacity to influence, challenge and negotiate,
- Clear communication to internal/external stakeholders.

  • FDA Regulatory Affairs Director

    il y a 2 jours

    Lyon, Auvergne-Rhône-Alpes, France Resourcing Group Temps plein

    Role DescriptionLine management, training of colleaguesEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirements.Training the team with EMEA / FDA requirementsQualificationsMin 8 years in regulatory affairs in medical deviceMin 4 years as Regulatory Affairs ManagerExperience with EMEA / FDA...

  • Regulatory Affairs Officer

    il y a 2 semaines

    Lyon, Auvergne-Rhône-Alpes, France Astek Temps plein

    What We Will Accomplish TogetherAlsinova, asubsidiary of the Astek Group, is a consulting firm specialized inLife Sciences. We support pharmaceutical, biotech, and medtech companies by providing high-level expertise inregulatory affairs, clinical development, data, quality, and pharmacovigilance. To support one of our major partners in thein vitro...

  • Quality Assurance and Regulatory Affairs France

    il y a 5 jours

    Lyon, France Valneva Temps plein

    The Pharmaceuticals Affairs intern supports pharmaceuticals affairs activities of Valneva France SAS as defined in article R.5124-2-3: Quality assurance, Wholesaling, Advertising, Regulatory Affairs. All activities are performed under the Pharmacien Responsable supervision. **Responsibilities**: > Exploitant/Distributor Quality Assurance › Support...

  • Regulatory Affairs Team Lead

    il y a 2 heures

    Lyon, France NonStop Consulting Temps plein

    **Regulatory Affairs Team Lead - Biocides**: **Location**:Home Working* - EU Wide Ref: BT.770000.1 / #LI-BT1 **Introduction**: Our client is a global scientific consultancy providing regulatory and research services to the chemical, biocidal, and agrochemical industries. The company has grown steadily through both organic expansion and strategic...

  • Chemical Regulatory Affairs Manager – LyonNonStop Consulting

    il y a 2 jours

    Lyon, France NonStop Consulting Temps plein

    Chemical Regulatory Manager – Lyon Our client, a leading global provider of market expansion services with a strong presence in the chemical industry, is seeking a skilled and dedicated Chemical Regulatory Manager. This pivotal role will be based at their offices on the periphery of Lyon, with a flexible hybrid model allowing for 2 days of home working per...

  • Regulatory - Label Specialist

    il y a 5 jours

    Lyon, France FMC Corporation Temps plein

    **Are you an experienced Regulatory Specialist and a first background in a regulatory related role in chemical, pharma or plant protection industry?** In this role, you will help support our French Regulatory Team with respect for the core values of FMC as a company. - “You can look forward to joining a wonderful team with a very good team spirit. In...

  • Regional Regulatory Manager

    il y a 1 semaine

    Lyon, France FMC AGRO POLSKA SP. Z O.O. Temps plein

    **About us** We, FMC Agricultural Solutions, provide innovative crop protection solutions to growers around the world. Thanks to the commitment of our 5,200 employees, we are one of the six largest crop protection manufacturers in the world. For any FMC office located in EU we are looking for a **Regional Regulatory Manager (m/ f/ d)** As a Regional...

  • Regulatory & Compliance Project Manager FMX

    il y a 1 jour

    Lyon, France Nemera Temps plein

    Regulatory & Compliance Project Manager F / M / X (CDI) – Based in Lyon (7e). Job Description We are looking for a unique person ready to make a difference and join our Compliance & Regulatory team as Regulatory & Compliance Project Manager based in Lyon. Within Nemeras headquarters you will lead the regulatory & compliance design projects of drug delivery...

  • Responsable Affaires Réglementaires Bu Cdmo

    il y a 5 jours

    Lyon, France Axplora Temps plein

    Axplora’s mission is to be a trusted manufacturing partner to the world's leading pharmaceutical and biotechnology companies. Driven by passion, curiosity, and dedication of our highly skilled employees, we aim to make them being proud to collaborate with our customers to deliver cutting-edge products for the benefit of humankind. While accomplishing our...

  • Regulatory Documentation Specialist

    il y a 1 semaine

    Lyon, Auvergne-Rhône-Alpes, France Consult Temps plein

    Vous êtes minutieux/se, rigoureux/se et avez une expérience en gestion de la sécurité des produits chimiques ?Expérimenté(e) en coordination de documentation réglementaire ?Vous souhaitez faire partie d'une organisation leader dans le domaine chimique en matière d'innovation produit et d'efficacité opérationnelle ?Nous recrutons actuellement un(e)...