Diagnostic Regulatory Affairs IH / Operations Specialist

La siguiente información tiene como objetivo proporcionar a los posibles candidatos una mejor comprensión de los requisitos para este puesto.
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

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- 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

Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the

📌 Diagnostic Regulatory Affairs IH (San Cugat del Vallés)
🏢 Grifols
📍 San Cugat del Vallés