Senior Regulatory Affairs Specialist

il y a 1 semaine

Grenoble, France BD Temps plein

Senior Regulatory Affairs Specialist – BD BD is seeking a Senior Regulatory Affairs Specialist to join our regulatory team in France (Eybens 38) or Spain (San Agustin del Guadalix). The role is responsible for ensuring the regulatory compliance of products and services for the assigned countries, maintaining alignment with authorities, customers, and internal stakeholders, and providing strategic regulatory analysis to leadership. Responsibilities Contribute to international regulatory submission strategies (excluding US), balancing compliance and business priorities. Prepare and submit documentation to authorities to register/notify products (pharmaceuticals or combination products), ensuring compliance with global and local regulations. Compile technical dossiers (e.g., eCTD Module 3 CMC) and manage post‑market obligations. Provide regulatory analysis for product launches and commercial communications. Lead or support regulatory input for change controls and ensure continuous compliance. Interact with regulatory authorities and internal partners, including during audits and tenders. Qualifications Master’s degree or higher in life sciences or scientific field (Pharmacist, Master in Regulatory Affairs). Minimum 5 years of experience in the pharmaceutical and/or medical device industry. Strong knowledge of regulatory requirements, particularly related to pharmaceuticals and eCTD submissions. Fluent in English (spoken and written); additional EU language is a plus. Strong analytical and communication skills; ability to work with both specialists and non‑specialists. Capable of managing multiple projects within deadlines and working collaboratively in cross‑functional teams. About BD BD is one of the largest global medical technology companies. Advancing the world of health™ is our Purpose, and it’s no small feat. We create transformative solutions that turn dreams into possibilities. Why Join Us? At BD, you will learn and work alongside inspirational leaders and colleagues who are passionate and committed to fostering an inclusive, growth‑centered, and rewarding culture. We welcome people who see the bigger picture and want to reinvent the future of health. You’ll discover a culture where you can learn, grow, and thrive, and make a difference. Equal Opportunity Employer Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Additional Information Salary and benefits are competitive and vary by location and experience. For more information, visit https://bd.com/careers. Job Details Senior level – Mid‑Senior level. Full‑time. Health Care Provider, Quality Assurance, and Product Management. Industries: Medical Equipment Manufacturing. #J-18808-Ljbffr

  • Senior Manager, Regulatory Affairs – Product Development F/H

    il y a 23 heures

    Grenoble, Auvergne-Rhône-Alpes, France Adoc Talent Management Temps plein

    For English, see bellow Référence : AMB-ATM25092E| Secteur d'activité : Technologies Médicales | Type de contrat : CDI | Région : Auvergne-Rhône-Alpes | Ville : Pont-de-Claix (Grenoble)EntrepriseAdoc Talent Management recrute pour son client un·e Senior Manager, Regulatory Affairs – Product Development (F/H). Notre client est...

  • Senior Manager Regulatory Affairs

    il y a 2 semaines

    Grenoble, France Adoc Talent Management Temps plein

    Adoc Talent Management recrute pour son client un·e Senior Manager, Regulatory Affairs - Product Development (F/H). Notre client est leader international dans le domaine des dispositifs médicaux (seringues préremplies, systèmes d'injection et de sécurité, etc.), utilisées par les plus grands laboratoires pharmaceutiques et biotechnologiques. Reconnue...

  • Associate Director, Regulatory Affairs – Drug–Device Programs

    il y a 1 semaine

    Grenoble, France Adoc Talent Management Temps plein

    A global leader in medical technologies is seeking an Associate Director of Regulatory Affairs to manage a team and drive regulatory strategy for drug-device combination products. The role involves leading regulatory interactions, managing a cross-functional team, and fostering a proactive regulatory culture. Solid experience in regulatory affairs and...

  • Associate Director, Regulatory Affairs Select Pharma

    il y a 1 semaine

    Grenoble, France Select Pharma Limited Temps plein

    Our client are at the forefront of drug delivery and injection technologies. They provide innovative solutions to pharmaceutical and biotechnology companies worldwide, with billions of devices manufactured annually across their seven international manufacturing facilities.In this strategic role based in Grenoble you will lead regulatory initiatives for...

  • Associate Director, Regulatory Affairs – Drug-Device Combination Products F/H

    il y a 1 semaine

    Grenoble, France Adoc Talent Management Temps plein

    Job Title: Associate Director, Regulatory Affairs – Drug-Device Combination ProductsReference: AMB-ATM25092D | Industry: Medical Technologies | Contract Type: Permanent | Region: Auvergne-Rhône-Alpes | City: Pont-de-Claix (Grenoble, France)Our client is a global leader in the field of medical devices (pre-filled syringes, injection and safety systems,...

  • Associate Director Regulatory Affairs

    il y a 2 semaines

    Grenoble, France Adoc Talent Management Temps plein

    Adoc Talent Management recrute pour son client, un·e Associate Director, Regulatory Affairs - Drug-Device Combination Products(F/H). Notre client est leader international dans le domaine des dispositifs médicaux (seringues préremplies, systèmes d'injection et de sécurité, etc.), utilisées par les plus grands laboratoires pharmaceutiques et...

  • Associate Director, Regulatory Affairs – Drug-Device Combination Products F/H

    il y a 7 jours

    Grenoble, Auvergne-Rhône-Alpes, France Adoc Talent Management Temps plein

    Resume For English, see bellowRéférence : AMB-ATM25092D| Secteur d'activité : Technologies Médicales | Type de contrat : CDI | Région : Auvergne-Rhône-Alpes | Ville : Pont-de-Claix (Grenoble)EntrepriseAdoc Talent Management recrute pour son client, un·e Associate Director, Regulatory Affairs – Drug-Device Combination Products (F/H)....

  • Ingénieur V&V Medical Devices H/F

    il y a 1 semaine

    Grenoble, France House of ABY Temps plein

    Dans le cadre de son développement, notre client - acteur majeur du secteur du medical devices - recherche un Ingénieur Vérification & Validation (V&V) pour renforcer son équipe qualité & design assurance. Votre mission principale sera d'assurer la Vérification et la Validation des produits, logiciels, bancs et moyens de tests, dans un environnement...

  • Biological Safety and Compliance Specialist

    il y a 4 jours

    Grenoble, France Corin Temps plein

    **Biological Safety and Compliance Specialist** We are looking for a Biological Safety and Compliance Specialist to join us on a permanent basis. Providing support to the Biological Compliance team, you will be liaising with other team members and staff in the Group to maintain on-going regulatory compliance of the Biological Safety Evaluation programme for...

  • Chargé-e de Développement Service Civique Solidarité Séniors

    il y a 2 jours

    Grenoble, France AND SC2S Temps plein

    **À propos de nous**: Le Service Civique Solidarité Seniors (SC2S) a vu le jour en 2021 à l'initiative d'Unis-Cité (l'association pionnière et spécialiste du Service Civique des jeunes en France), grâce au soutien de l'Institution de Retraite Complémentaire Malakoff-Humanis, l'Agence du Service Civique et le Ministère Délégué à l'Autonomie. Il...