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Senior EMEA Regulatory Affairs Specialist

Date: 27 nov. 2022

Lieu: LE HAILLAN, 33, FR, 33185

Entreprise: Steris Corporation

Chez STERIS, nous aidons nos clients à créer un monde plus sain et plus sûr en leur fournissant des produits et services de santé et de sciences du vivant, partout dans le monde.

Duties

Reporting to the Regulatory Affairs Manager, your missions will be as followed:

  • Identify regulatory requirements for new products or product enhancements early in the product development cycle.
  • Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims.
  • As Regulatory representative for the STERIS Bordeaux facility, review product revision requests to assure compliance with regulatory requirements
  • Work on product teams to develop regulatory strategy based on regulatory submission requirements, including new product developments in the Bordeaux facility
  • Review and approve labeling and marketing literature.
  • Keep abreast of multiple regulatory issues that impact STERIS including EU, national requirements and translate the impact of these on the business.

Required experience

With an engineering degree or a BAC+5 in a technical field (Chemistry, Sciences...), you have at least 5 years of experience in the field of regulatory affairs in the medical device industry. You have an extensive understanding of chemical/ medical device industry, in particular the workings of the regulatory and legislative environment around the world. Understanding and anticipating business needs and interests allow you to operate in a business-driven model, providing quick, salient analysis and concrete action plans, and devise proactive approaches/responses. You keep abreast of industry developments and changes in the political environment. Your rigor, adaptability and organizational skills will allow you to evolve in a demanding department. You have excellent communications, listening, planning, and diplomacy skills which allow you to build relationships and influence decision makers. You interact effectively and show credibility at senior levels.

To evolve in an international structure, your written and spoken English must be fluent.

 

STERIS est l'un des principaux fournisseurs de produits et services qui répondent aux besoins des domaines de croissance de la santé : procédures, dispositifs, vaccins et produits biologiques.  Nous existons pour remplir notre MISSION D'AIDER NOS CLIENTS À CRÉER UN MONDE PLUS SAIN ET PLUS SÛR. STERIS est une entreprise de 3 milliards de dollars, cotée en bourse (NYSE : STE) avec environ 16 000 associés et Clients dans plus de 100 pays.

En sa qualité d'employeur, STERIS s'efforce de respecter le principe de l'égalité des chances.