Diagnostic Regulatory Affairs IH / Operations Specialist

Would you like to join an international team working to improve the future of the healthcare sector? Do you want to contribute to improving the lives of millions of people? Grifols is a global healthcare company that since 1909 has been improving the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and we develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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.

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.

• 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 with regulatory requirements.
• Assist commercial teams with regulatory documentation for tenders and customers

Contract of Employment: Permanent position

Location: Sant Cugat del Vallès.

www.grifols.com

Location: SPAIN : Spain : Sant Cugat del Valles:[[cust_building]]

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

¿Te gustaría unirte a 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 global 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.

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.

• 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 with regulatory requirements.
• Assist commercial teams with regulatory documentation for tenders and customers

Contract of Employment: Permanent position

Location: Sant Cugat del Vallès.

www.grifols.com

Ubicación: SPAIN : España : Sant Cugat del Valles:[[cust_building]]

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).