¿Te gustaría un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía general del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.
Mission
We are looking for an Immunohematology (IH) / Operations Regulatory Affairs Specialist to join Diagnostic Regulatory Affairs department. The RRAA Specialist will be responsible for the preparation of technical documentation, submission, following up and controlling of product registration and/or renewal, variations dossiers, as well as giving support to Regulatory transversal project.




What your responsibilities will be
- Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.
- Prepare technical documentation based on the R&D; inputs.
- Coordinate the preparation of the documents needed for regulatory submissions with R&D;, manufacturing and QA departments.
- Define and provide guidance on the interpretation and application of regulatory requirements and standards worldwide.
- Prepare and send official responses to any Health Authority questions.
- Review and assess regulatory impact on product or manufacturing changes.
- Adapt licenses to current regulations.
- Manage/coordinate the delivery of product samples or labels related to product registration/renewal/change processes.
- Revise, approve and/or coordinate packaging material.
- Write and Manage SOPs.
- Review technical documents to ensure coherence and compliance wit

📌 Diagnostic Regulatory Affairs Ih (Cataluña)
🏢 Grifols Shared Services North America
📍 Cataluña