Diagnostic Regulatory Affairs IH / Operations Specialist
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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.
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 knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential
📌 Diagnostic Regulatory Affairs IH (Madrid)
🏢 Grifols
📍 Madrid
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